|
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 | S008 |
Date Received | 09/28/2009 |
Decision Date | 08/16/2010 |
Product Code |
FTR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | normal 180 day track no user fee |
Supplement Reason | postapproval study protocol - osb |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |