PMA P030053S071

Device: Mentor® MemoryGel® Silicone Gel-Filled Breast Implants
Applicant: Mentor Corp.
PMA number: P030053
Supplement: S071
Product code: FTR
Decision date: 2024-12-04
Classification: General, Plastic Surgery
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: approval for a manufacturing change to the frequency of in-process cleaning steps for two primary packaging and assembly wash stations

Current openFDA PMA Record#

Device: Mentor® MemoryGel® Silicone Gel-Filled Breast Implants
Applicant: Mentor Corp.
PMA number: P030053
Supplement: S071
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2024-12-04
Decision code: APPR
Date received: 2023-08-23
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing change to the frequency of in-process cleaning steps for two primary packaging and assembly wash stations