- Device
- Mentor MemoryShape Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S039
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2021-06-04
- Decision code
- OK30
- Date received
- 2021-05-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes in the primary packaging equipment used in the manufacturing process for MemoryShape, MemoryGel, and Saline-Filled andSpectrum Breast Implants