PMA P030053S078

Device: MENTOR™ MemoryGel™ Enhance Breast Implants
Applicant: Mentor Corp.
PMA number: P030053
Supplement: S078
Product code: FTR
Decision date: 2025-02-14
Classification: General, Plastic Surgery
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: After discussing the changes in sterilization validation with SMEs and the sponsor, it was determined that the change does not pose a concern.

Current openFDA PMA Record#

Device: MENTOR™ MemoryGel™ Enhance Breast Implants
Applicant: Mentor Corp.
PMA number: P030053
Supplement: S078
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2025-02-14
Decision code: OK30
Date received: 2025-01-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: After discussing the changes in sterilization validation with SMEs and the sponsor, it was determined that the change does not pose a concern.