IDEAL IMPLANT Structured Breast Implant
FDA premarket approval P120011/S020 · decided 2020-07-31
Approval details
- PMA number
- P120011
- Supplement
- S020
- 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
- 2020-07-02
- Decision date
- 2020-07-31
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- a change in manufacturing process at their approved TSS site
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