|
Device | MENTOR MEMORYGEL 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 | S002 |
Date Received | 12/20/2006 |
Decision Date | 02/08/2008 |
Product Code |
FTR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | normal 180 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO A LOW BLEED PATCH DESIGN FOR THE DEVICE. |