Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | MENTOR MEMORYSHAPE BREAST IMPLANTS |
Generic Name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
Regulation Number | 878.3540 |
Applicant | MENTOR WORLDWIDE LLC 33 Technology Drive Irvine, CA 92618 |
PMA Number | P060028 |
Supplement Number | S011 |
Date Received | 04/08/2015 |
Decision Date | 05/08/2015 |
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 CHANGE TO USE SEGREGATION BASKETS FOR IN-PROCESS SHELL COMPONENT IN THE PRODUCTION OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY. |
|
|