- Device
- Mentor® MemoryShape® Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S050
- 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