PMA P030053S004
- Device
- MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S004
- Product code
- FTR
- Decision date
- 2007-04-27
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- APPROVAL TO REVISE THE POST-APPROVAL STUDY TO ALLOW FOR THE VOLUNTARY RATHER THAN MANDATORY PARTICIPATION OF ALL PATIENTS, IRRESPECTIVE OF THE TYPE OF IMPLANT (I.E., MEMORYGEL IMPLANT OR SALINE IMPLANTS) THEY RECEIVE.
Current openFDA PMA Record#
- Device
- MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S004
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2007-04-27
- Decision code
- APPR
- Date received
- 2007-03-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL TO REVISE THE POST-APPROVAL STUDY TO ALLOW FOR THE VOLUNTARY RATHER THAN MANDATORY PARTICIPATION OF ALL PATIENTS, IRRESPECTIVE OF THE TYPE OF IMPLANT (I.E., MEMORYGEL IMPLANT OR SALINE IMPLANTS) THEY RECEIVE.