Anesthesiology
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- CardiovascularReview Panel
- MiscellaneousMiscellaneous
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- LPBCardiac Ablation Percutaneous Catheter3Product Code
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- LWWPulse-Generator, Single Chamber, Single3Product Code
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- 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
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- MIEHeart-Valve, Allograft3Product Code
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- MIRShunt, Portosystemic, Endoprosthesis3Product Code
- MLVTranscatheter Septal Occluder3Product Code
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- MOUIntravascular Radiation Delivery System3Product Code
- MRMDefibrillator, Implantable, Dual-Chamber3Product Code
- MTESystem, Pacing, Temporary, Acute, Internal Atrial Defibrillation3Product Code
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- P190020BioFreedom Drug Coated Coronary Stent SystemAPPRPMA Approval
- P210014SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid ExAPPRPMA Approval
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- 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
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- 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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- 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
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- 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
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- SEGLeadless Cardiac Resynchronization Therapy (Crt)3Product 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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RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- MEDTRONIC VASCULAR
- Trade Name
- RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Generic Name
- Coronary drug-eluting stent
- Decision Date
- 4/28/2017
- Days to Decision
- 213 days
- Decision Code
- APPR
- FDA Decision
- Approval