PMA P060028S005
- Device
- MENTOR MEMORYSHAPE BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S005
- Product code
- FTR
- Decision date
- 2015-03-02
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- APPROVAL FOR A CHANGE TO A LOW BLEED PATCH DESIGN FOR MEMORYSHAPE BREAST IMPLANTS.
Current openFDA PMA Record#
- Device
- MENTOR MEMORYSHAPE BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S005
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2015-03-02
- Decision code
- APPR
- Date received
- 2014-12-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE TO A LOW BLEED PATCH DESIGN FOR MEMORYSHAPE BREAST IMPLANTS.