|
Device | MemoryGel Silicone Gel-Filled Breast Implants |
Generic Name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
Regulation Number | 878.3540 |
Applicant | MENTOR CORP. 33 TECHNOLOGY DRIVE IRVINE, CA 92618 |
PMA Number | P030053 |
Supplement Number | S053 |
Date Received | 07/01/2019 |
Decision Date | 08/28/2020 |
Product Code |
FTR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the completion of the Mentor MemoryGel Large Post-Approval Study Re-Op Phase close out plan. |