PMA P060028S006
- Device
- MEMORYSHAPE BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S006
- Product code
- FTR
- Decision date
- 2015-03-05
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- CHANGE TO THE ASSIGNED SHELF LIFE OF THE FINAL GEL MIX, IMPLEMENTATION OF NEW EQUIPMENT AND A CHANGE TO THE GEL MIXTURE SAMPLING PROCEDURE.
Current openFDA PMA Record#
- Device
- MEMORYSHAPE BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S006
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2015-03-05
- Decision code
- OK30
- Date received
- 2015-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE ASSIGNED SHELF LIFE OF THE FINAL GEL MIX, IMPLEMENTATION OF NEW EQUIPMENT AND A CHANGE TO THE GEL MIXTURE SAMPLING PROCEDURE.