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 | CARPENTIER-EDWARDS(R) PERICARDIAL BIOPROSTHESIS, MODEL 2700 |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P860057 |
Supplement Number | S003 |
Date Received | 10/30/1995 |
Decision Date | 12/06/1996 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITIONAL MANUFACTURING FACILITY LOCATED AT BAXTER HEALTHCARE CORPORATION, EDWARDS CVS DIVISION, 1435 MCGAW AVE., IRVINE, CA 92714 |
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