IDEAL IMPLANT Structured Breast Implant
FDA premarket approval P120011/S018 · decided 2020-04-03
Approval details
- PMA number
- P120011
- Supplement
- S018
- 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
- 2020-03-17
- Decision date
- 2020-04-03
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Add 100% visual inspection and manual flash removal from the valve seat after cryogenic deflashing.
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