|
Device | NATRELLE Silicone-Filled Breast Implants |
Generic Name | Prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P990074 |
Supplement Number | S046 |
Date Received | 05/26/2021 |
Decision Date | 06/25/2021 |
Product Code |
FWM |
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 Change to implement an Electronic Data Acquisition (EDA) System to record and store the cycle parameters of the dry heat sterilization process used in the manufacture of Allergan Natrelle® Saline-Filled Breast Implants and Allergan Natrelle® Silicone-Filled Breast Implants |