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 | 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 | S060 |
Date Received | 05/07/2021 |
Decision Date | 06/04/2021 |
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 Changes in the primary packaging equipment used in the manufacturing process for MemoryShape, MemoryGel, and Saline-Filled andSpectrum Breast Implants. |
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