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
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- 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
- P000037ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXAAPPRPMA Approval
- P990046ATS OPEN PIVOT BILEAFLET HEART VALVEAPPRPMA Approval
- P970002MONOSTRUT CARDIAC VALVE PROSTHESISAPPRPMA Approval
- P900060CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)APPRPMA Approval
- P870038STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESESAPPRPMA Approval
- P850006DUROMEDICS BILEAFLET HEART VALVEAPPRPMA Approval
- P830039OMNISCEINCE PROSTHETIC CARDIAC VALVEAPWDPMA Approval
- P810002BILEAFLET-CENTER OPENING CARDIAC VALVEAPPRPMA Approval
- P790018MEDTRONIC(R) HALL PROSTHETIC HEART VALVEAPWDPMA Approval
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- 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
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- MOUIntravascular Radiation Delivery System3Product Code
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- MVKWearable Automated External Defibrillator3Product Code
- MWGSystem, Oxygen, Aqueous3Product Code
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- NAPCardiac Support Mesh WrapNProduct Code
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- 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
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- NPTAortic Valve, Prosthesis, Percutaneously Delivered3Product Code
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- 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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- OBCOccluder, Internal Vessel, Temporary3Product Code
- OBDBarrier, Adhesion, Cardiovascular3Product Code
- OCMSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation3Product Code
- ODTTissue Adhesive, Aortic AneurysmorrhaphyFProduct Code
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- 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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- PNFAortic Stent3Product Code
- PNYAbsorbable Coronary Drug-Eluting Stent3Product Code
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- QMGShockwave Intravascular Lithotripsy System3Product Code
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- 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
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- 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
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- 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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STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- EDWARDS LIFESCIENCES, LLC.
- Trade Name
- STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES
- Generic Name
- HEART-VALVE, MECHANICAL
- Decision Date
- 9/27/1991
- Days to Decision
- 1551 days
- Decision Code
- APPR
- FDA Decision
- Approval