Ideal Implant Structured Breast implant
FDA premarket approval P120011/S027 · decided 2023-11-18
Approval details
- PMA number
- P120011
- Supplement
- S027
- 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
- 2023-11-02
- Decision date
- 2023-11-18
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Transferring of certain QC tests to the manufacturing site.
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