PMA P060028S033
- Device
- Mentor MemoryShape Breast Implants
- Applicant
- Mentor Worldwide, LLC
- Product code
- FTR
- Decision date
- 2020-07-01
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Mentor MemoryShape Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S033
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2020-07-01
- Decision code
- APPR
- Date received
- 2019-08-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.