Ideal Implant Structured Breast Implant
FDA premarket approval P120011/S011 · decided 2018-06-28
Approval details
- PMA number
- P120011
- Supplement
- S011
- Supplement type
- 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
- 2018-06-08
- Decision date
- 2018-06-28
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Change to the bubble specification for the inner and outer shell to increase the allowable number of microscopic bubbles less than or equal to 0.020 inches in size from 5 bubbles to 10 bubbles.
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