IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
FDA premarket approval P120011/S006 · decided 2017-06-27
Approval details
- PMA number
- P120011
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Bimini Health Tech
- Date received
- 2016-07-28
- Decision date
- 2017-06-27
- Days to decision
- 334 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Approval for updated patient and physician labeling that includes 5 year follow-up clinical data
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