- Device
- MemoryGel/MemoryGel Xtra Breast Implants
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S062
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2021-10-27
- Decision code
- APPR
- Date received
- 2021-05-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the patient and physician labeling including a boxed warning and a patient decision checklist.