IDEAL IMPLANT Structured Breast Implant
FDA premarket approval P120011/S022 · decided 2021-10-27
Approval details
- PMA number
- P120011
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IDEAL IMPLANT Structured Breast Implant
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Bimini Health Tech
- Date received
- 2021-05-27
- Decision date
- 2021-10-27
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Approval for changes to the patient and physician labeling including a boxed warning and a patient decision checklist.
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