|
Device | Mentor MemoryShape® Silicone Gel-Filled Breast Implant |
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 | S051 |
Date Received | 12/11/2023 |
Decision Date | 03/11/2024 |
Product Code |
FTR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for packaging changes to primary packaging components |