- Device
- MENTOR MemoryShape Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S044
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2022-03-08
- Decision code
- APPR
- Date received
- 2022-02-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised statistical analysis plan (SAP) for the post-approval study (PAS) protocol. The SAP has been submitted to align with protocol changes.