|
Device | Mentor MemoryShape Breast Implants |
Generic Name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
Regulation Number | 878.3540 |
Applicant | MENTOR WORLDWIDE LLC 33 Technology Drive Irvine, CA 92618 |
PMA Number | P060028 |
Supplement Number | S038 |
Date Received | 03/08/2021 |
Decision Date | 09/24/2021 |
Product Code |
FTR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for implementation of a new texturing press in the manufacturing process for MemoryGel® Silicone Gel-Filled Breast Implants and MemoryShape Gel-Filled Breast Implants. |