Anesthesiology
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- CardiovascularReview Panel
- 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
- 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
- P190020BioFreedom Drug Coated Coronary Stent SystemAPPRPMA Approval
- P210014SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid ExAPPRPMA Approval
- P170030ORSIRO Sirolimus Eluting Coronary Stent SystemAPPRPMA Approval
- P170008EluNIR™ Ridaforolimus Eluting Coronary Stent SystemAPPRPMA Approval
- P160043RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMAPPRPMA Approval
- P150003SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMAPPRPMA Approval
- P110013RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMAPPRPMA Approval
- P110010PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMAPPRPMA Approval
- P110019XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMAPPRPMA Approval
- P100023ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS)APWDPMA Approval
Show All 15 Submissions
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- 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
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- 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
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- PCXArtificial Chordae Tendinae Delivery SystemNProduct Code
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- 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
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- QNZPowered Communication System For Emergency UseNProduct Code
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- QOCTemporary Non-Roller Type Left Or Right Heart Support Blood PumpNProduct Code
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- QSKHybrid Stent Graft, Thoracic Aortic Lesion Treatment3Product Code
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- 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
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- SFRHypertension Machine Learning-Based Notification Software2Product Code
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- SGOPercutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures2Product 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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ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS)
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Boston Scientific Corp.
- Trade Name
- ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS)
- Generic Name
- Coronary drug-eluting stent
- Decision Date
- 4/22/2011
- Days to Decision
- 309 days
- Decision Code
- APWD
- FDA Decision
- Withdrawal after approval