|
Device | NATRELLE 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 | S018 |
Date Received | 02/23/2007 |
Decision Date | 05/17/2007 |
Product Code |
FWM |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A TRADE NAME CHANGE FROM INAMED SALINE-FILLED BREAST IMPLANTS TO NATRELLE SALINE-FILLED BREAST IMPLANTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NATRELLE SALINE-FILLED BREAST IMPLANTS AND IS INDICATED FOR 1) BREAST AUGMENTATION FOR WOMEN 18 YEARS OR OLDER; AND 2) BREAST RECONSTRUCTION. |