PMA P030053S019
- Device
- MEMORYGEL BREAST IMPLANT
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S019
- Product code
- FTR
- Decision date
- 2015-01-16
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: RE-OP PHASE PROTOCOL AS A NEW POST-APPROVAL STUDY REQUIREMENT.
Current openFDA PMA Record#
- Device
- MEMORYGEL BREAST IMPLANT
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S019
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2015-01-16
- Decision code
- APPR
- Date received
- 2014-08-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: RE-OP PHASE PROTOCOL AS A NEW POST-APPROVAL STUDY REQUIREMENT.