|
Device | NATRELLE SILICONE-FILLED BREST 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 | S018 |
Date Received | 12/31/2012 |
Decision Date | 03/05/2015 |
Product Code |
FTR |
Advisory Committee |
General & Plastic Surgery |
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 UPDATED LABELING TO INCLUDE 10 YEAR DATA FROM THE CORE CLINICAL STUDY. |