IDEAL IMPLANT Structured Breast Implant
FDA premarket approval P120011/S009 · decided 2018-03-13
Approval details
- PMA number
- P120011
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2017-10-05
- Decision date
- 2018-03-13
- Days to decision
- 159 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Approval for a manufacturing site located at Vesta Intermediate Funding Inc., 9900 S 57th Street, Franklin, Wisconsin.
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