PMA P030053S053
- Device
- MemoryGel Silicone Gel-Filled Breast Implants
- Applicant
- Mentor Corp.
- Product code
- FTR
- Decision date
- 2020-08-28
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Approval of the completion of the Mentor MemoryGel Large Post-Approval Study Re-Op Phase close out plan.
Current openFDA PMA Record#
- Device
- MemoryGel Silicone Gel-Filled Breast Implants
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S053
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2020-08-28
- Decision code
- APPR
- Date received
- 2019-07-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the completion of the Mentor MemoryGel Large Post-Approval Study Re-Op Phase close out plan.