- Device
- IDEAL IMPLANT Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S022
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2021-10-27
- Decision code
- APPR
- Date received
- 2021-05-27
- Supplement type
- Normal 180 Day Track No User Fee
- 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.