PMA P030053S016
- Device
- MEMORY GEL SILICONE GEL- FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S016
- Product code
- FTR
- Decision date
- 2014-03-18
- 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 THIRTY-ONE STYLES INCLUDING SIXTEEN SMOOTH ROUND ULTRA HIGH PROFILE DEVICES: 350-5135BC, 350-5160BC, 350-5180BC, 350-5215BC, 350-5240BC, 350-5270BC, 350-5295BC, 350-5320BC, 350-5350BC, 350-5375BC, 350-5400BC, 350-5430BC, 350-5455BC, 350-5480BC, 350-5535BC, AND 350-5590BC; AND FIFTEEN SILTEX® ROUND ULTRA HIGH PROFILE DEVICES: 354-5135, 354-5160, 354-5185, 354-5215, 354-5240, 354-5270, 354-5295, 354-5320, 354-5350, 354-5375, 354-5400, 354-5430, 354-5455, 354-5480, AND 354-5535.
Current openFDA PMA Record#
- Device
- MEMORY GEL SILICONE GEL- FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S016
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2014-03-18
- Decision code
- APPR
- Date received
- 2013-12-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF THIRTY-ONE STYLES INCLUDING SIXTEEN SMOOTH ROUND ULTRA HIGH PROFILE DEVICES: 350-5135BC, 350-5160BC, 350-5180BC, 350-5215BC, 350-5240BC, 350-5270BC, 350-5295BC, 350-5320BC, 350-5350BC, 350-5375BC, 350-5400BC, 350-5430BC, 350-5455BC, 350-5480BC, 350-5535BC, AND 350-5590BC; AND FIFTEEN SILTEX® ROUND ULTRA HIGH PROFILE DEVICES: 354-5135, 354-5160, 354-5185, 354-5215, 354-5240, 354-5270, 354-5295, 354-5320, 354-5350, 354-5375, 354-5400, 354-5430, 354-5455, 354-5480, AND 354-5535.