PMA P030053S013
- Device
- MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S013
- Product code
- FTR
- Decision date
- 2014-02-24
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- APPROVAL FOR THE ADDITION OF SEVEN STYLES INCLUDING FOUR SMOOTH ROUND ULTRA HIGH PROFILE DEVICES: 350-5650BC, 350-57000BC, 350-5750BC, AND 350-5800BC; AND THREE SILTEX ROUND ULTRA HIGH PROFILE DEVICES: 354-5590, 354-5650, AND 354-5700.
Current openFDA PMA Record#
- Device
- MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S013
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2014-02-24
- Decision code
- APPR
- Date received
- 2013-01-25
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR THE ADDITION OF SEVEN STYLES INCLUDING FOUR SMOOTH ROUND ULTRA HIGH PROFILE DEVICES: 350-5650BC, 350-57000BC, 350-5750BC, AND 350-5800BC; AND THREE SILTEX ROUND ULTRA HIGH PROFILE DEVICES: 354-5590, 354-5650, AND 354-5700.