|
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 | S061 |
Date Received | 08/29/2022 |
Decision Date | 07/12/2023 |
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 including the final results from the BIFS-001 NBIR-Arm Clinical Study in the labeling documents for Natrelle Silicone-Filled Breast Implants and Natrelle INSPIRA Silicone-Filled Breast Implants. |