PMA P030053S072

Device: Mentor MemoryGel® Breast Implants
Applicant: Mentor Corp.
PMA number: P030053
Supplement: S072
Product code: FTR
Decision date: 2025-08-06
Classification: General, Plastic Surgery
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: Approval for a change to the coating used on the MemoryGel® shell mandrel tooling used during the shell spray process to make the shell component used in currently approved Smooth and Siltex MemoryGel® Breast Implant product families

Current openFDA PMA Record#

Device: Mentor MemoryGel® Breast Implants
Applicant: Mentor Corp.
PMA number: P030053
Supplement: S072
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2025-08-06
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 change to the coating used on the MemoryGel® shell mandrel tooling used during the shell spray process to make the shell component used in currently approved Smooth and Siltex MemoryGel® Breast Implant product families