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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 | S020 |
Date Received | 03/08/2017 |
Decision Date | 04/04/2017 |
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 Addition of Vinatoru equipment for seal strength testing of packaging components that are used for Mentor Saline-Filled and SPECTRUM® Breast Implants, MemoryGel® Silicone Gel-Filled Breast Implants and MemoryShapeTM Breast Implants and their accessories. |