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 (R) SYSTEM |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | Medtronic, Inc. 710 Medtronic Parkway Minneapolis,, MN 55432 |
PMA Number | P130021 |
Supplement Number | S004 |
Date Received | 04/10/2014 |
Decision Date | 09/02/2014 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW COMPRESSION LOADING SYSTEM (G4 CLS), A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH WESTPORT LIMITED, SYNERGY HEALTH PLACE, LODGE ROAD, WESTPORT,CO., MAYO, IRELAND, AND THE GAMMA STERILIZATION OF THE FINISHED G4 CLS. |
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