PMA P060028S016
- Device
- MENTOR MEMORYSHAPE BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S016
- Product code
- FTR
- Decision date
- 2016-12-20
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Approval for updated labeling to include the results of the 10 year clinical study.
Current openFDA PMA Record#
- Device
- MENTOR MEMORYSHAPE BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S016
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2016-12-20
- Decision code
- APPR
- Date received
- 2016-02-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updated labeling to include the results of the 10 year clinical study.