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 | S005 |
Date Received | 01/29/2001 |
Decision Date | 04/09/2001 |
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 A NEW SERIES OF SIZES FOR THE STYLE 363 SALINE-FILLED BREAST IMPLANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MCGHAN SALINE-FILLED BREAST IMPLANTS, STYLE 363LF AND IS INDICATED FOR: 1) BREAST AUGMENTATION FOR WOMEN 18 YEARS OR OLDER AND 2) BREAST RECONSTRUCTION. |
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