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 IMPLANT |
Generic Name | prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant | Allergan 2525 dupont dr. irvine, CA 92612 |
PMA Number | P990074 |
Supplement Number | S012 |
Date Received | 07/23/2002 |
Decision Date | 08/08/2002 |
Product Code |
FWM |
Advisory Committee |
General & Plastic Surgery |
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 1) DESIGN MODIFICATIONS TO THE PATCH CONFIGURATION, 2) CHANGES TO THE PATCH VULCANIZATION PROCESS, AND 3) CHANGES TO THE VALVE VULCANIZATION PROCESS. |
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