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 TRANSCATHER HEART VALVE |
Generic Name | aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. one edwards way irvine, CA 92614 |
PMA Number | P100041 |
Supplement Number | S055 |
Date Received | 07/17/2014 |
Decision Date | 10/19/2015 |
Withdrawal Date
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03/18/2019 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 review track for 30-day notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING LINE CHANGE AND THE USE OF AMMONIUM PERFLUOROOCTANOATE (APFO) FREE RESIN AT LENZING PLASTICS GMBH, AN EDWARDS APPROVED SUPPLIER. |
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