IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
FDA premarket approval P120011/S005 · decided 2016-05-13
Approval details
- PMA number
- P120011
- Supplement
- S005
- 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
- 2016-04-15
- Decision date
- 2016-05-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Manufacturing sequence change: baffle shell slitting process was moved to follow the 2-inch hole die-cutting step, instead of preceding it. The facility is located in Specialty Silicone Fabricators (SSF), 2761 Walnut Avenue, Tustin, CA 92780.
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