PMA P030053S088

Device: MemoryGel Silicone Gel-Filled Breast Implant
Applicant: Mentor Corp.
PMA number: P030053
Supplement: S088
Product code: FTR
Decision date: 2026-04-30
Classification: General, Plastic Surgery
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: Dimensional modification to the Small Outer Thermoform Tray mold to increase clearance between inner and outer trays by increasing from 0.031" to 0.050".

Current openFDA PMA Record#

Device: MemoryGel Silicone Gel-Filled Breast Implant
Applicant: Mentor Corp.
PMA number: P030053
Supplement: S088
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2026-04-30
Decision code: OK30
Date received: 2026-04-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Dimensional modification to the Small Outer Thermoform Tray mold to increase clearance between inner and outer trays by increasing from 0.031" to 0.050".