IDEAL IMPLANT Structured Breast Implant
FDA premarket approval P120011/S013 · decided 2018-08-22
Approval details
- PMA number
- P120011
- Supplement
- S013
- 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
- 2018-07-25
- Decision date
- 2018-08-22
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Replace the current 100% shell inspection for thickness with a zero acceptance number (c=0, AQL=1.0%) shell sampling plan for thickness at the Vesta Intermediate Funding Inc located at 9900 S 57th Street, Franklin, Wisconsin.
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