PMA P030053S005
- Device
- MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S005
- Product code
- FTR
- Decision date
- 2008-03-05
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- APPROVAL FOR AN ALTERNATIVE SPRAY METHOD FOR MANUFACTURING THE SHELL COMPONENT OF THE MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS.
Current openFDA PMA Record#
- Device
- MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S005
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2008-03-05
- Decision code
- APPR
- Date received
- 2007-05-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ALTERNATIVE SPRAY METHOD FOR MANUFACTURING THE SHELL COMPONENT OF THE MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS.