| 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 | EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES |
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| Generic Name | Aortic valve, prosthesis, percutaneously delivered |
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| Applicant | EDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614 |
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| PMA Number | P130009 |
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| Supplement Number | S034 |
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| Date Received | 04/15/2015 |
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| Decision Date | 10/09/2015 |
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| Product Code |
NPT |
| Docket Number | 15M-4017 |
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| Notice Date | 11/03/2015 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT01314313
|
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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? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE SAPIEN XT TRANSCATHETER HEART VALVE, MODEL 9300TFX, AND ACCESSORIES. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO EITHER SEVERE NATIVE CALCIFIC AORTIC STENOSIS OR FAILURE (STENOSED, INSUFFICIENT, OR COMBINED) OF A SURGICAL BIOPROSTHETIC AORTIC VALVE 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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