|
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 | S057 |
Date Received | 06/30/2021 |
Decision Date | 07/30/2021 |
Product Code |
FTR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Installation of a new patch curing oven and electronic data acquisition system for the manufacture of silicone-filled and saline-filled breast implants at Allergan's Costa Rica facility. |