IDEAL IMPLANT Structured Breast Implant
FDA premarket approval P120011/S024 · decided 2022-01-26
Approval details
- PMA number
- P120011
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process 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
- 2021-12-22
- Decision date
- 2022-01-26
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Trelleborg Sealing Solutions US, Inc. to resume fabrication of silicone shells using new DipTech automated equipment.
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