IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
FDA premarket approval P120011/S003 · decided 2016-11-17
Approval details
- PMA number
- P120011
- Supplement
- S003
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Bimini Health Tech
- Date received
- 2016-03-28
- Decision date
- 2016-11-17
- Days to decision
- 234 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Approval for re-sterilization of the IDEAL IMPLANT® Saline-filled Breast Implant up to a total of 44 hours exposure time if the primary dry heat sterilization (DHS) cycle is interrupted and/or aborted
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