|
Device | Mentor MemoryGel SiliconeGel-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 | S040 |
Date Received | 03/20/2017 |
Decision Date | 04/19/2017 |
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 Changes to the routine batch auditing plans for measurement of shell properties and gel cohesion performance for the MemoryShape and MemoryGel breast implants. |