|
Device | NATRELLE INSPIRA 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 | S031 |
Date Received | 12/05/2014 |
Decision Date | 06/03/2015 |
Product Code |
FTR |
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 LINE EXTENSION IDENTIFIED AS THE NATRELLE INSPIRA SILICONE-FILLED BREAST IMPLANTS TO ADD BREAST IMPLANT OPTIONS TO THE NATRELLE SILICONE-FILLED BREAST IMPLANTS. |