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 | INAMED SILICONE-FILLED BREAST IMPLANTS |
Generic Name | prosthesis, breast, noninflatable, internal, silicone gel-filled |
Regulation Number | 878.3540 |
Applicant | Allergan 2525 dupont dr. irvine, CA 92612 |
PMA Number | P020056 |
Supplement Number | S001 |
Date Received | 01/31/2007 |
Decision Date | 08/22/2007 |
Product Code |
FTR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | normal 180 day track no user fee |
Supplement Reason | express gmp supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE IN LA AURORA DE HEREDIA, COSTA RICA. |
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