PMA P030053S021
- Device
- MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S021
- Product code
- FTR
- Decision date
- 2014-12-15
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- CHANGE TO AUTOMATE THE EXISTING SILICONE ELASTOMER SHEET CUTTER USED TO CUT PART COMPONENTS FOR MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS, MENTOR MEMORYGELSILICONE GEL-FILLED BREAST IMPLANTS AND MENTOR MEMORYSHAPE BREAST IMPLANTS MANUFACTURED ATMENTOR'S IRVING, TEXAS FACILITY.
Current openFDA PMA Record#
- Device
- MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S021
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2014-12-15
- Decision code
- OK30
- Date received
- 2014-11-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO AUTOMATE THE EXISTING SILICONE ELASTOMER SHEET CUTTER USED TO CUT PART COMPONENTS FOR MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS, MENTOR MEMORYGELSILICONE GEL-FILLED BREAST IMPLANTS AND MENTOR MEMORYSHAPE BREAST IMPLANTS MANUFACTURED ATMENTOR'S IRVING, TEXAS FACILITY.