PMA P030053S031
- Device
- MEMORYGEL BREAST IMPLANT
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S031
- Product code
- FTR
- Decision date
- 2016-02-12
- 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: to enroll women with both MemoryGel and MemoryShape in a single study to address device specific and device class safety endpoints and updates to the study timeline.
Current openFDA PMA Record#
- Device
- MEMORYGEL BREAST IMPLANT
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S031
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2016-02-12
- Decision code
- APPR
- Date received
- 2015-09-16
- 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: to enroll women with both MemoryGel and MemoryShape in a single study to address device specific and device class safety endpoints and updates to the study timeline.