PMA P030053S006
- Device
- MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S006
- Product code
- FTR
- Decision date
- 2009-08-24
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- APPROVAL FOR LABELING CHANGES AFTER FOCUS GROUP INPUT.
Current openFDA PMA Record#
- Device
- MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S006
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2009-08-24
- Decision code
- APPR
- Date received
- 2008-04-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES AFTER FOCUS GROUP INPUT.