Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- MiscellaneousMiscellaneous
- QHGDefect Measurement Tool2Product Code
- NQOProsthesis, Spinous Process Spacer/Plate3Product Code
- HTMStimulator, Osteogenesis, Electric, Battery-Operated, Invasive3Product Code
- HWFProsthesis, Ligament3Product Code
- LMLLigaments And Tendons, Synthetic3Product Code
- LMNCeramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses3Product Code
- LOEStimulator, Invasive Bone Growth3Product Code
- LOFStimulator, Bone Growth, Non-Invasive3Product Code
- LPFProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented3Product Code
- LPQStimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep3Product Code
- LWAProsthesis, Ligament, Ptfe3Product Code
- LXCMonitor, Pressure, IntracompartmentalUProduct Code
- LXYProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer3Product Code
- LZJProsthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-ConstrainedUProduct Code
- MBDProsthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer3Product Code
- MBJFastener, Fixation, Biodegradable, Hard Tissue3Product Code
- MBSFiller, Bone Void, Non-Osteoinduction3Product Code
- MCVSpinal Pedicle Screw, Fixation, Appliance System3Product Code
- MDIProsthesis, Rib ReplacementUProduct Code
- MJOProsthesis, Intervertebral Disc3Product Code
- MJTProsthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented3Product Code
- MOZAcid, Hyaluronic, Intraarticular3Product Code
- P180040TRILURONAPPRPMA Approval
- P170016SYNOJOYNTAPPRPMA Approval
- P160057TRIVISCAPPRPMA Approval
- P170007DUROLANEAPPRPMA Approval
- P140005GENVISC 850APPRPMA Approval
- P150010HYMOVISAPPRPMA Approval
- P110005SINOVIAL (SODIUM HYALURONATE 0.8%)APPRPMA Approval
- P090031MONOVISCAPPRPMA Approval
- P080020GEL-ONEAPPRPMA Approval
- P010029EUFLEXXA (1% SODIUM HYALURONATE)APPRPMA Approval
- P080020Gel-One3PMA Approval
- P980044SUPARTZ FX and VISCO-33PMA Approval
- P030019Orthovisc3PMA Approval
- P940015Synvisc and Synvisc-One3PMA Approval
- P080020Gel-One3PMA Approval
- P170007DUROLANE3PMA Approval
- P980044SUPARTZ device family, SUPARTZ FX and VISCO-33PMA Approval
- P080020Gel-One3PMA Approval
- P980044SUPARTZ device family, SUPARTZ FX and VISCO-33PMA Approval
- P110005GELSYN-33PMA Approval
- P110005GELSYN-33PMA Approval
- P030019Orthovisc3PMA Approval
- P170007DUROLANE3PMA Approval
- P080020Gel-One3PMA Approval
- P080020Gel-One3PMA Approval
- P980044SUPARTZ FX, VISCO-33PMA Approval
- P170007DUROLANE3PMA Approval
- P110005GELSYN-33PMA Approval
- P110005GELSYN-33PMA Approval
- P170007DUROLANE3PMA Approval
- P080020Gel-One3PMA Approval
- P980044SUPARTZ FX and VISCO-33PMA Approval
- P940015Synvisc, Synvisc-One3PMA Approval
- P110005GELSYN-33PMA Approval
- P160057TriVisc3PMA Approval
- P140005GenVisc 8503PMA Approval
- P010029EUFLEXXA (1% Sodium Hyaluronate)3PMA Approval
- P080020Gel-One3PMA Approval
- P080020Gel-One3PMA Approval
- P940015Synvisc/Synvisc-One3PMA Approval
- P090031Monovisc3PMA Approval
- P010029Euflexxa (1% Sodium Hyaluronate)3PMA Approval
- P170007Durolane, Hyaluronic Acid, Stabilized Single Injection3PMA Approval
- P080020Gel-One3PMA Approval
- P170007Durolane3PMA Approval
- P170007Durolane, Hyaluronic Acid, Stabilized Single Injection3PMA Approval
- P010029EUFLEXXA (1% Sodium Hyaluronate)3PMA Approval
- P180040TRILURON3PMA Approval
- P080020Gel-One3PMA Approval
- P170007DUROLANE3PMA Approval
- P080020Gel-One3PMA Approval
- P980044SUPARTZ FX; VISCO-33PMA Approval
- P940015Synvisc One3PMA Approval
- P940015Synvisc and Synvisc-One3PMA Approval
- P940015Synvisc One3PMA Approval
- P080020Gel-One3PMA Approval
- P980044Supartz FX and Visco-33PMA Approval
- P010029EUFLEXXA3PMA Approval
- P980044SUPARTZ FX/VISCO-33PMA Approval
- P940015Synvisc and Synvisc-One3PMA Approval
- P170007DUROLOANE3PMA Approval
- P980044SUPARTZ FX and VISCO-33PMA Approval
- P080020Gel-One3PMA Approval
- P980044SUPARTZ FX and VISCO-33PMA Approval
- P980044Supartz FX, Visco-33PMA Approval
- P980044Supartz FX, Visco-33PMA Approval
- P170016SYNOJOYNT3PMA Approval
- P110005GELSYN-33PMA Approval
- P010029Euflexxa (1% Sodium Hyaluronate)3PMA Approval
- P980044SUPARTZ FX and VISCO-33PMA Approval
- P080020GEL-ONE3PMA Approval
- P080020Gel-One3PMA Approval
- P980044Supartz FX and Visco-33PMA Approval
- P980044SUPARTZ FX and VISCO-33PMA Approval
- P080020Gel-One3PMA Approval
- P010029EUFLEXXA (1% Sodium Hyaluronate)3PMA Approval
- P080020Gel-One3PMA Approval
- P980044SUPARTZ FX / VISCO-33PMA Approval
- P160057TRIVISC3PMA Approval
- P170007DUROLANE3PMA Approval
- P090031MONOVISC High Molecular Weight Hyaluronan3PMA Approval
- P980044SUPARTZ FX and VISCO-33PMA Approval
- P940015SYNVISC ONE3PMA Approval
- P940015Synvisc3PMA Approval
- P980044Supartz FX and Visco-33PMA Approval
- P980044Supartz Device Family3PMA Approval
- P080020Gel-One3PMA Approval
- P110005GELSYN-33PMA Approval
- P980044SUPARTZ FX & VISCO-33PMA Approval
- P080020GEL-ONE3PMA Approval
- P940015SYNVISC3PMA Approval
- P080020GEL-ONE3PMA Approval
- P080020GEL-ONE3PMA Approval
- P150010HYMOVIS3PMA Approval
- P940015SYNVISC3PMA Approval
- P090031MONOVISC3PMA Approval
- P080020GEL-ONE(R)3PMA Approval
- P980044SUPARTZ FX VISCO-33PMA Approval
- P980044SUPARTZ FX, VISCO-33PMA Approval
- P950027HYALGAN3PMA Approval
- P080020GEL-ONE3PMA Approval
- P980044SUPARTZ Device Family, Supartz FX, VISCO-33PMA Approval
- P110005Gel-Syn™3PMA Approval
- P980044SUPARTZ FX3PMA Approval
- P940015SYNVISC ONE3PMA Approval
- P080020GEL-ONE3PMA Approval
- P080020GEL-ONE3PMA Approval
- P980044SUPARTZ FX3PMA Approval
- P030019ORTHOVISC3PMA Approval
- P090031MONOVISC3PMA Approval
- P980044SUPARTZ FX3PMA Approval
- P980044SUPARTZ FX3PMA Approval
- P980044VISCO-33PMA Approval
- P980044SUPARTZ FX3PMA Approval
- P080020GEL-ONE3PMA Approval
- P140005GENVISC 8503PMA Approval
- P080020GEL-ONE3PMA Approval
- P080020GEL-ONE3PMA Approval
- P150010HYMOVIS3PMA Approval
- P080020GEL-ONE3PMA Approval
- P940015SYNVISC, SYNVISC-ONE3PMA Approval
- P980044SUPARTZ FX3PMA Approval
- P080020GEL-ONE3PMA Approval
- P940015SYNVISC3PMA Approval
- P980044SUPARTZ FX3PMA Approval
- P010029EUFLEXXA (1% SODIUM HYALURONATE)3PMA Approval
- P090031MONOVISC INJECTABLE INTRA-ARTICULAR DEVICES3PMA Approval
- P030019ORTHOVISC INJECTABLE INTRA-ARTICULAR DEVICES3PMA Approval
- P010029EUFLEXXA (1% SODIUM HYALURONATE)3PMA Approval
- P980044SUPARTZ3PMA Approval
- P010029EUFLEXXA (1% SODIUM HYALURONATE)3PMA Approval
- P090031MONOVISC3PMA Approval
- P010029EUFLEXXA3PMA Approval
- P980044SUPARTZ3PMA Approval
- P980044SUPARTZ3PMA Approval
- P980044SUPARTZ3PMA Approval
- P980044SUPARTZ3PMA Approval
- P080020GEL-ONE3PMA Approval
- P980044SUPARTZ3PMA Approval
- P080020GEL-ONE3PMA Approval
- P080020GEL-ONE3PMA Approval
- P080020GEL ONE3PMA Approval
- P080020GEL-ONE3PMA Approval
- P940015SYNVISC, SYNVISC-ONE3PMA Approval
- P940015SYNVISC AND SYNVISC ONE3PMA Approval
- P030019ORTHOVISC3PMA Approval
- P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURON3PMA Approval
- P090031ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN3PMA Approval
- P030019ORTHOVISC, HIGH MOLECULAR WEIGHT HYALURONAN3PMA Approval
- P090031MONOVISC INJECTABLE INTRA-ARTICULAR DEVICE3PMA Approval
- P080020GEL-ONE3PMA Approval
- P980044SUPARTZ3PMA Approval
- P010029EUFLEXXA (1% SODIUM HYALURONATE)3PMA Approval
- P940015SYNVISC AND SYNVISC-ONE3PMA Approval
- P940015SYNVISC3PMA Approval
- P110005SINOVIAL (SODIUM HYALURONATE 0.8%)3PMA Approval
- P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN3PMA Approval
- P010029EUFLEXXA3PMA Approval
- P090031MONOVISC3PMA Approval
- P940015SYNVISC3PMA Approval
- P980044SUPARTZ3PMA Approval
- P010029EUFLEXXA (1% SODIUM HYALURONATE)3PMA Approval
- P940015SYNVISC3PMA Approval
- P080020GEL-ONE3PMA Approval
- P950027HYALGAN3PMA Approval
- P080020GEL-ONE3PMA Approval
- P980044SUPARTZ3PMA Approval
- P980044SUPARTZ3PMA Approval
- P940015SYNVISC AND SYNVISC-ONE3PMA Approval
- P010029EUFLEXXA3PMA Approval
- P010029EUFLEXXA (1% SODIUM HYALURONATE)3PMA Approval
- P080020GEL-ONE3PMA Approval
- P080020GEL-ONE3PMA Approval
- P080020GEL-ONE3PMA Approval
- P980044SUPARTZ3PMA Approval
- P940015SYNVISC AND SYNVISC-ONE3PMA Approval
- P010029EUFLEXXA (1% SODIUM HYALURONATE)3PMA Approval
- P080020GEL-ONE3PMA Approval
- P980044SUPARTZ3PMA Approval
- P940015SYNVISC & SYNVISC-ONE3PMA Approval
- P010029EUFLEXXA (1% SODIUM HYALURONATE)3PMA Approval
- P010029EUFLEXXA (1% SODIUM HYALURONATE)3PMA Approval
- P940015SYNVISC & SYNVISC-ONE3PMA Approval
- P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN3PMA Approval
- P010029EUFLEXXA (1% SODIUM HYALURONATE)3PMA Approval
- P940015SYNVISC & SYNVISC-ONE (HYLAN G-F 20)3PMA Approval
- P940015SYNVISC AND SYNVISC-ONE3PMA Approval
- P940015SYNVISC AND SYNVISC-ONE3PMA Approval
- P010029EUFLEXXA (1% SODIUM HYALURONATE)3PMA Approval
- P080020GEL-ONE3PMA Approval
- P940015SYNVISC & SYNVISC-ONE3PMA Approval
- P030019ORTHOVISC3PMA Approval
- P940015SYNVISC (HYLAN G-F 20) AND SYNVISC-ONE (HYLAN G-F 20)3PMA Approval
- P010029EUFLEXXA (1% SODIUM HYALURONATE)3PMA Approval
- P980044SUPARTZ3PMA Approval
- P940015SYNVISC & SYNVISC-ONE3PMA Approval
- P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN3PMA Approval
- P950027HYALGAN3PMA Approval
- P940015SYNVISC-ONE (HYLAN G-F 20)3PMA Approval
- P010029EUFLEXXA ( 1% SODIUM HYALURONATE)3PMA Approval
- P010029EUFLEXXA (1% SODIUM HYALURONATE)3PMA Approval
- P980044SUPARTZ3PMA Approval
- P940015SYNVISC3PMA Approval
- P980044SUPARTZ JOINT FLUID THERAPY3PMA Approval
- P980044SUPARTZ3PMA Approval
- P010029EUFLEXXA 1% SODIUM HYALURONATE3PMA Approval
- P940015SYNVISC3PMA Approval
- P940015SYNVISC & SYNVISC-ONE (HYLAN G-F 20)3PMA Approval
- P940015SYNVISC-ONE3PMA Approval
- P980044SUPARTZ3PMA Approval
- P940015SYNVISC HYLAN G-F 203PMA Approval
- P950027HYALGAN3PMA Approval
- P950027HYALGAN3PMA Approval
- P950027HYALGAN3PMA Approval
- P030019ORTHOVISC SODIUM HYALURONATE3PMA Approval
- P010029EUFLEXXA3PMA Approval
- P010029EUFLEXXA 1% SODIUM HYALURONATE3PMA Approval
- P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN3PMA Approval
- P980044SUPARTZ3PMA Approval
- P980044SUPARTZ3PMA Approval
- P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN3PMA Approval
- P980044SUPARTZ3PMA Approval
- P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN3PMA Approval
- P010029NUXFLEXXA (SODIUM HYALURONATE)3PMA Approval
- P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN3PMA Approval
- P980044SUPARTZ3PMA Approval
- P010029EUFLEXXA3PMA Approval
- P950027HYALGAN3PMA Approval
- P030019ORTHOVISC SODIUM HYALURONATE3PMA Approval
- P010029EUFLEXXA (1% SODIUM HYALURONATE)3PMA Approval
- P980044SUPARTZ3PMA Approval
- P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURON3PMA Approval
- P030019ORTHOVISC HIGH MODECULAR WEIGHT HYALURNAN3PMA Approval
- P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN3PMA Approval
- P980044SUPARTZ3PMA Approval
- P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN3PMA Approval
- P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN3PMA Approval
- P940015SYNVISC HYLAN G-F 203PMA Approval
- P940015SYNVISC HYLAN G-F 203PMA Approval
- P940015SYNVISC3PMA Approval
- P940015SYNVISC (HYLAN G-F 20)3PMA Approval
- P940015SYNVISC(HYLAN G-F 20)3PMA Approval
- P980044SUPARTZ FX3PMA Approval
- P940015SYNVISC (HYLAN G-F 20)3PMA Approval
- P950027HYALGAN3PMA Approval
- P940015SYNVISC (HYLAN G-F 20)3PMA Approval
- P950027HYALGAN(R)3PMA Approval
- P950027HYALGAN(R)3PMA Approval
- P940015SYNVISC (HYLAN G-F 20)3PMA Approval
- P940015SYNVISC (HYLAN G-F 20)3PMA Approval
- P940015SYNVISC (HYLAN G-F 203PMA Approval
- P940015SYNVISC ONE3PMA Approval
- P950027HYALGAN(R)3PMA Approval
- P950027HYALGAN(R)3PMA Approval
- MPKSemi-Constrained Metal/Polymer Finger Joint ProsthesisFProduct Code
- MPWFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction3Product Code
- MQOProsthetic Disc Nucleus DeviceNProduct Code
- MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented3Product Code
- MRWSystem, Facet Screw Spinal DeviceUProduct Code
- NBNGenerator, Shock-Wave, For Pain Relief3Product Code
- NCOImplant, Cartilage, For Articular Cartilage Repair3Product Code
- NEGFinger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis3Product Code
- NEKFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction3Product Code
- NJLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing3Product Code
- NOXFiller, Bone Void, Synthetic Peptide3Product Code
- NRAProsthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing3Product Code
- NTGProsthesis, Ankle, Uncemented, Non-Constrained3Product Code
- NVRIntervertebral Fusion Device With Bone Graft, Solid-Sphere, LumbarUProduct Code
- NXTProsthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing3Product Code
- OJZFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - HdeFProduct Code
- OKDFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone NonunionFProduct Code
- OMEExtracorporeal Shock Wave Treatment3Product Code
- OMXHigh Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger ProsthesisFProduct Code
- OVOProsthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation3Product Code
- OYRFiller, Bone Void, Recombinant Platelet-Derived Growth FactorNProduct Code
- PBUBone Void Filler, SyringeNProduct Code
- PFMHemibridge SystemNProduct Code
- PGMGrowing Rod SystemUProduct Code
- PGNGrowing Rod System- Magnetic ActuationUProduct Code
- PIXElbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented ProsthesisNProduct Code
- PJYOsseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees3Product Code
- PNWProsthesis, Metatarsophalangeal Joint Cartilage Replacement Implant3Product Code
- PWGSpinal Fixation SystemNProduct Code
- QCGFiller, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow LesionsNProduct Code
- QESReherniation Reduction Device3Product Code
- QGPPosterior Ratcheting Rod SystemNProduct Code
- QHPVertebral Body Tethering SystemNProduct Code
- QNNTalus SpacerFProduct Code
- QRRFiller, Bone Void, Calcium Compound Containing Gentamicin2Product Code
- QJDAbsorbable Metallic Bone Fixation Fastener2Product Code
- QKWShoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis2Product Code
- QVVMedial Knee Implanted Shock Absorber2Product Code
- QWLIntraoperative Surgical Angle Measurement Tool2Product Code
- QRUImplant, Resorbable, For Articular Osteochondral Repair3Product Code
- QWKProsthesis, Posterior Spinal Elements3Product Code
- QYQProsthesis, Total Talus Replacement With Soft Tissue Attachment Sites, MetalFProduct Code
- QZOWearable Vibration Device For Orthopedic Use2Product Code
- QZYSpinal Fusion Device With Quaternary Ammonium Compound Coating2Product Code
- QZZLimb And Joint Salvage Device With Coating For Bacteria Reduction2Product Code
- QVLAbsorbable Gel For Intraoperative Use In Spine Surgery2Product Code
- SFAProsthesis, Finger, Semi-Constrained, Metal/Polymer3Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SUPARTZ FX and VISCO-3
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- SEIKAGAKU CORP.
- Trade Name
- SUPARTZ FX
- Generic Name
- Acid, hyaluronic, intraarticular
- Decision Date
- 1/24/2001
- Days to Decision
- 785 days
- Decision Code
- APPR
- FDA Decision
- Approval