PMA P060028S001
- Device
- MEMORYSHAPE BREAST IMPLANTS, CONTOUR PROFILE GEL IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S001
- Product code
- FTR
- Decision date
- 2014-09-09
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- APPROVAL FOR FOUR ADDITIONAL MEMORYSHAPE¿ BREAST IMPLANT STYLES (MM+, MH, TM+ AND LM+).
Current openFDA PMA Record#
- Device
- MEMORYSHAPE BREAST IMPLANTS, CONTOUR PROFILE GEL IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S001
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2014-09-09
- Decision code
- APPR
- Date received
- 2014-03-26
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR FOUR ADDITIONAL MEMORYSHAPE¿ BREAST IMPLANT STYLES (MM+, MH, TM+ AND LM+).