|
Device | NATRELLE 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 | S009 |
Date Received | 08/18/2008 |
Decision Date | 04/22/2009 |
Product Code |
FTR |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT00689871
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING THAT REFLECTS THE FOCUS GROUP STUDY FINDINGS AND 7-YEAR CORE STUDY DATA. |