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 | MCGHAN SALINE-FILLED BREAST IMPLANTS |
Generic Name | Prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P990074 |
Supplement Number | S014 |
Date Received | 02/13/2003 |
Decision Date | 03/12/2003 |
Product Code |
FWM |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MANUFACTURE MCGHAN SALINE-FILLED BREAST IMPLANTS, STYLES 168, 163, 363LF, AND 468 AT INAMED CORPORATION'S FACILITY LOCATED IN BARREAL DE HEREDIA, COSTA RICA. |
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