PMA P060028S056
- Device
- MENTOR™ MemoryShape™ Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S056
- Product code
- FTR
- Decision date
- 2025-08-08
- Classification
- General, Plastic Surgery
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Approval for a modification of final finished device testing frequency.
Current openFDA PMA Record#
- Device
- MENTOR™ MemoryShape™ Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S056
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2025-08-08
- Decision code
- OK30
- Date received
- 2025-07-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a modification of final finished device testing frequency.