PMA P030053S026
- Device
- MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S026
- Product code
- FTR
- Decision date
- 2015-04-15
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- CHANGE TO ADD AN ALTERNATE SUPPLIER FOR ISOPROPYL ALCOHOL (IPA) USED IN THE MANUFACTURE OF MENTOR MEMORYGEL BREAST IMPLANTS AT MENTOR'S IRVING, TEXAS FACILITY.
Current openFDA PMA Record#
- Device
- MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S026
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2015-04-15
- Decision code
- OK30
- Date received
- 2015-03-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO ADD AN ALTERNATE SUPPLIER FOR ISOPROPYL ALCOHOL (IPA) USED IN THE MANUFACTURE OF MENTOR MEMORYGEL BREAST IMPLANTS AT MENTOR'S IRVING, TEXAS FACILITY.