|
Device | Mentor 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 | S047 |
Date Received | 05/29/2018 |
Decision Date | 06/26/2018 |
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 an automated lot verification process prior to primary packaging and expansion of the primary packaging room configuration. |