PMA P060028S007
- Device
- MENTOR MEMORYSHAPE BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S007
- Product code
- FTR
- Decision date
- 2015-03-17
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- CHANGE TO AUTOMATE THE GEL MIX MATERIAL SAMPLING PROCESS TO BE USED IN THE PRODUCTION OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
Current openFDA PMA Record#
- Device
- MENTOR MEMORYSHAPE BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S007
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2015-03-17
- Decision code
- OK30
- Date received
- 2015-02-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO AUTOMATE THE GEL MIX MATERIAL SAMPLING PROCESS TO BE USED IN THE PRODUCTION OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.