|
Device | Natrelle Saline-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 | S043 |
Date Received | 11/04/2019 |
Decision Date | 12/04/2019 |
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 Changes in the sterilization validation of Natrelle Saline-Filled Breast Implants, including a change in the D-value of the biological indicators and a change in the sterilization validation approach. |