IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
FDA premarket approval P120011/S007 · decided 2016-10-20
Approval details
- PMA number
- P120011
- Supplement
- S007
- Supplement type
- 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
- 2016-09-21
- Decision date
- 2016-10-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Extra valve competence testing on valves prior to assembly into implants, implemented during commercial production start-up, will be discontinued; andthe extra valve competence testing on valves in finished (i.e., packaged and sterilized) implants during commercial production start-up, will be discontinued. However, valve competence testing on valves in finished implants will continue to meet the requirements of the AQL sampling specified in Ideal Implants Finished Product Specification FP 001.
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