|
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 | S019 |
Date Received | 11/22/2016 |
Decision Date | 05/08/2017 |
Product Code |
FTR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for implementation of a CO2 shell soaking process as an alternative to the current isopropyl alcohol (IPA) shell soaking process for removal of primarily low molecular weight (LMW) siloxanes from high temperature vulcanized (HTV) round and shaped breast implant shells. |