IDEAL IMPLANT SALINE FILLED BREAST IMPLANT
FDA premarket approval P120011/S001 · decided 2015-08-27
Approval details
- PMA number
- P120011
- Supplement
- S001
- 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
- 2015-07-24
- Decision date
- 2015-08-27
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- AN INCREASE IN THE SCALE AND CAPACITY OF SHELL PRODUCTION EQUIPMENT, AND THE ELIMINATION FOR THE NEED OF THE CONTRACT MANUFACTURER TO DILUTE THE SILICONE DISPERSION MATERIAL.
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