IDEAL IMPLANT Structured Breast Implant
FDA premarket approval P120011/S012 · decided 2018-08-06
Approval details
- PMA number
- P120011
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IDEAL IMPLANT Structured Breast Implant
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Bimini Health Tech
- Date received
- 2018-06-11
- Decision date
- 2018-08-06
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Approval for an extension of the shelf life for the fill tube assembly (FTA) from 3 years to 5 years
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