|
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 | S037 |
Date Received | 02/14/2017 |
Decision Date | 04/13/2017 |
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 MemoryGel® Silicone Gel-Filled Breast Implants Smooth product line involving additional breast implant options with increased fill volume but within approved dimension and volume ranges. |