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. |
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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 | S024 |
Date Received | 02/20/2015 |
Decision Date | 03/17/2015 |
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 AUTOMATE THE GEL MIX MATERIAL SAMPLING PROCESS TO BE USED IN THE PRODUCTION OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY. |
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