|
Device | Mentor MemoryShape Silicone Gel-Filled 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 | S025 |
Date Received | 06/06/2017 |
Decision Date | 09/01/2017 |
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 of a product line extension to the currently marketed MemoryShape Silicone Gel-Filled Breast Implants product line involving additional breast implant options with volume and dimensional values that are bracketed within the currently approved ranges for the commercially available MemoryShape implants. |