IDEAL IMPLANT Structured Breast Implant
FDA premarket approval P120011/S015 · decided 2019-09-19
Approval details
- PMA number
- P120011
- Supplement
- S015
- Supplement type
- 135 Review Track For 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
- 2019-05-21
- Decision date
- 2019-09-19
- Days to decision
- 121 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Approval for a change to the manufacturing tooling and heighten quality control for patch component #7 inside diameter.
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