| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | MEDTRONIC COREVALVE SYSTEM |
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| Generic Name | Aortic valve, prosthesis, percutaneously delivered |
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| Applicant | Medtronic, Inc.
710 Medtronic Parkway
Minneapolis,, MN 55432 |
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| PMA Number | P130021 |
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| Supplement Number | S002 |
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| Date Received | 02/27/2014 |
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| Decision Date | 06/12/2014 |
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| Product Code |
NPT |
| Docket Number | 14M-0867 |
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| Notice Date | 07/08/2014 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT01240902
|
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | Yes |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE MEDTRONIC COREVALVE SYSTEM. THIS DEVICE IS INDICATED FOR RELIEF OF AORTIC STENOSIS IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO SEVERE NATIVE CALCIFIC AORTIC STENOSIS (AORTIC VALVE AREA <=1.0 CM2 OR AORTIC VALVE AREA INDEX <=0.6 CM2/M2, A MEAN AORTIC VALVE GRADIENT OF >=40 MM HG, OR A PEAK AORTIC-JET VELOCITY OF >=4.0 M/S) AND WITH NATIVE ANATOMY APPROPRIATE FOR THE 23, 26, 29, OR 31 MM VALVE SYSTEM WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT HIGH OR GREATER RISK FOR OPEN SURGICAL THERAPY (I.E., SOCIETY OF THORACIC SURGEONS OPERATIVE RISK SCORE >=8% OR AT A >=15% RISK OF MORTALITY AT 30 DAYS). |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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