PMA P060028S019

Device: MENTOR MEMORYSHAPE BREAST IMPLANTS
Applicant: Mentor Worldwide, LLC
PMA number: P060028
Supplement: S019
Product code: FTR
Decision date: 2017-05-08
Classification: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
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.

Current openFDA PMA Record#

Device: MENTOR MEMORYSHAPE BREAST IMPLANTS
Applicant: Mentor Worldwide, LLC
PMA number: P060028
Supplement: S019
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2017-05-08
Decision code: APPR
Date received: 2016-11-22
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.