Anesthesiology
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- MiscellaneousMiscellaneous
- QODExtracorporeal Circuit And Accessories For Long Term Respiratory Cariodpulmonary FailureNProduct Code
- QRJLaser-Powered Inferior Vena Cava Filter Retrieval Catheter2Product Code
- KPKMarker, Ostia, Aorto-Saphenous Vein2Product Code
- DSQVentricular (Assist) Bypass3Product Code
- FZCProsthesis, Arterial Graft, Bovine Carotid Artery3Product Code
- LOTPulse-Generator, Program Module3Product Code
- LOZArtificial Heart3Product Code
- LPASystem, Esophageal Pacing3Product Code
- LPBCardiac Ablation Percutaneous Catheter3Product Code
- LPCDevice, Angioplasty, Laser, Coronary3Product Code
- LWOPulse-Generator, Single Chamber, Sensor Driven, Implantable3Product Code
- LWPImplantable Pulse Generator, Pacemaker (Non-Crt)3Product Code
- LWQHeart-Valve, Mechanical3Product Code
- LWRHeart-Valve, Non-Allograft Tissue3Product Code
- LWSImplantable Cardioverter Defibrillator (Non-Crt)3Product Code
- LWTOccluder, Balloon, Vena-Cava3Product Code
- LWWPulse-Generator, Single Chamber, Single3Product Code
- LWXDevice. Laser Peripheral Angioplasty3Product Code
- LWZTissue Graft Of Less Than 6mm3Product Code
- LXATissue Graft Of 6mm And Greater3Product Code
- MADCatheter, Percutaneous (Valvuloplasty)3Product Code
- MAEOccluder, Patent Ductus, Arteriosus3Product Code
- MAFStent, Coronary3Product Code
- MCXCatheter, Coronary, Atherectomy3Product Code
- MFADevice, Removal, Pacemaker Electrode, Percutaneous3Product Code
- MGBDevice, Hemostasis, Vascular3Product Code
- MIEHeart-Valve, Allograft3Product Code
- MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment3Product Code
- MIRShunt, Portosystemic, Endoprosthesis3Product Code
- MLVTranscatheter Septal Occluder3Product Code
- P120021AMPLATZER PFO OCCLUDERAPPRPMA Approval
- P040040AMPLATZER MUSCULAR VSD OCCLUDERAPPRPMA Approval
- P050006GORE HELEX SEPTAL OCCLUDERAPPRPMA Approval
- P000049CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOADAPPRPMA Approval
- P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMAPPRPMA Approval
- MNOSystem, Laser, Transmyocardial Revascularization3Product Code
- MOMSystem, Hemodynamic, Implantable3Product Code
- MOUIntravascular Radiation Delivery System3Product Code
- MRMDefibrillator, Implantable, Dual-Chamber3Product Code
- MTESystem, Pacing, Temporary, Acute, Internal Atrial Defibrillation3Product Code
- MUQGlue, Surgical, Arteries3Product Code
- MVKWearable Automated External Defibrillator3Product Code
- MWGSystem, Oxygen, Aqueous3Product Code
- MWHPulmonic Valved ConduitFProduct Code
- NAPCardiac Support Mesh WrapNProduct Code
- NAVGraft, Bypass, Coronary ArteryFProduct Code
- NGVSystem, Appendage Closure, Left Atrial3Product Code
- NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)3Product Code
- NIMStent, Carotid3Product Code
- NINStent, Renal3Product Code
- NIOStent, Iliac3Product Code
- NIPStent, Superficial Femoral Artery3Product Code
- NIQCoronary Drug-Eluting Stent3Product Code
- NIUStent, Superficial Femoral Artery, Drug-Eluting3Product Code
- NIVCoronary Covered StentFProduct Code
- NKEPulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)3Product Code
- NKMMitral Valve Repair Devices3Product Code
- NPTAortic Valve, Prosthesis, Percutaneously Delivered3Product Code
- NPUProsthesis, Mitral Valve, Percutaneously Delivered3Product Code
- NPVPulmonary Valve Prosthesis Percutaneously DeliveredFProduct Code
- NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes3Product Code
- NVYPermanent Defibrillator Electrodes3Product Code
- NVZPulse Generator, Permanent, Implantable3Product Code
- NWXCatheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring3Product Code
- OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter3Product Code
- OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation3Product Code
- OBCOccluder, Internal Vessel, Temporary3Product Code
- OBDBarrier, Adhesion, Cardiovascular3Product Code
- OCMSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation3Product Code
- ODTTissue Adhesive, Aortic AneurysmorrhaphyFProduct Code
- OHAHeart Valve, More Than Minimally Manipulated AllograftUProduct Code
- OJERight Ventricular Bypass (Assist) DeviceFProduct Code
- OJXDrug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode3Product Code
- ONUDrug-Eluting Peripheral Transluminal Angioplasty Catheter3Product Code
- OSRPacemaker/Icd/Crt Non-Implanted Components3Product Code
- OZDTemporary Non-Roller Type Left Heart Support Blood Pump3Product Code
- OZGTranscatheter Septal Occluder (Atrial)3Product Code
- OZHTranscatheter Septal Occluder (Ventricular)3Product Code
- PAPAortic Heart Valve, More Than Minimally Manipulated AllograftFProduct Code
- PCWImplantable Pulse Generator, Programmer And Battery ChargerNProduct Code
- PCXArtificial Chordae Tendinae Delivery SystemNProduct Code
- PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment3Product Code
- PIZCombination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve3Product Code
- PJQAgent, Occluding, Vascular, Permanent3Product Code
- PKKStent Delivery SystemNProduct Code
- PNFAortic Stent3Product Code
- PNYAbsorbable Coronary Drug-Eluting Stent3Product Code
- PRCDrug-Coated Peripheral Transluminal Angioplasty Catheter3Product Code
- PRLIliac Covered Stent, Arterial3Product Code
- QANStent, Iliac Vein3Product Code
- QBIAcute Coronary Syndrome Event Detector3Product Code
- QCTScaffold, Dissection Repair3Product Code
- QFVImplantable Pulse Generator3Product Code
- QLJPatient Monitor With Independent Remote Display And OperationNProduct Code
- QLLLeft Ventricular Ejection Fraction Screening ToolNProduct Code
- QLMIntensive Care Unit, Respiratory Failure And Hemodynamic Instability ToolNProduct Code
- QLNExtracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19NProduct Code
- QMGShockwave Intravascular Lithotripsy System3Product Code
- QNYRemote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation MonitoringNProduct Code
- QNZPowered Communication System For Emergency UseNProduct Code
- QOAPpg Sensor Wearable For Hypercoagulation Detection And Covid-19 ScreeningNProduct Code
- QOCTemporary Non-Roller Type Left Or Right Heart Support Blood PumpNProduct Code
- QIKOrgan Care System (Ocs) Heart System3Product Code
- QSKHybrid Stent Graft, Thoracic Aortic Lesion Treatment3Product Code
- QWACardiovascular Delivery Catheter System Positioning And Stabilization Device1Product Code
- QWMStent Graft, Bypass, Superficial Femoral Artery3Product Code
- QXOCardiovascular Machine Learning-Based Notification Software2Product Code
- QWCPulmonary Stent3Product Code
- QVQExtravascular Support For An Arteriovenous Fistula For Vascular Access3Product Code
- QXVTemperature Regulation Device For Esophageal Protection During Cardiac Ablation2Product Code
- QWNStent Graft, Infrapopliteal, Venous Arterialization3Product Code
- QXUEsophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation2Product Code
- QXXCoronary Artery Disease Machine Learning-Based Notification Software2Product Code
- QYEReduced Ejection Fraction Machine Learning-Based Notification Software2Product Code
- QVGEmbolization Agent, Vascular3Product Code
- QYIAblation Catheter, Renal Denervation3Product Code
- QYUInfant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use2Product Code
- QZIPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation3Product Code
- QZKEndovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions3Product Code
- QZUTemporary Embolization Assist Device, Peripheral2Product Code
- NPWPercutaneously Delivered Prostheses And Tricuspid Valves3Product Code
- OOBDrug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter3Product Code
- NPSTricuspid Valve Repair Device, Percutaneously Delivered3Product Code
- SATPulmonary Hypertension Machine Learning-Based Notification Software2Product Code
- SBKArtificial Chordae Tendineae Surgical Replacement System2Product Code
- SBQAtrial Fibrillation Risk Prediction Machine Learning-Based Notification Software2Product Code
- QXYOscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification2Product Code
- SCZPercutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures2Product Code
- NXWScaffold, Infrapopliteal, Absorbable3Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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GORE HELEX SEPTAL OCCLUDER
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- W.L. GORE & ASSOCIATES,INC
- Trade Name
- GORE HELEX SEPTAL OCCLUDER
- Generic Name
- Transcatheter septal occluder
- Decision Date
- 8/11/2006
- Days to Decision
- 528 days
- Decision Code
- APPR
- FDA Decision
- Approval