IDEAL IMPLANT® Structured Breast Implant
FDA premarket approval P120011/S023 · decided 2023-02-01
Approval details
- PMA number
- P120011
- Supplement
- S023
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IDEAL IMPLANT® Structured Breast Implant
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Bimini Health Tech
- Date received
- 2021-08-27
- Decision date
- 2023-02-01
- Days to decision
- 523 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Approval for a new manufacturing site at Bentec Medical OpCo, LLC, 1380 E Beamer St. Woodland CA 95776.
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