Puregraft Serene Breast Implant
FDA premarket approval P120011 · decided 2014-11-14
Approval details
- PMA number
- P120011
- Trade name
- Puregraft Serene Breast Implant
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Bimini Health Tech
- Date received
- 2012-06-25
- Decision date
- 2014-11-14
- Days to decision
- 872 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- APPROVAL FOR THE IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT. THIS DEVICE IS INDICATED FOR WOMEN AT LEAST 18 YEARS OLD UNDERGOING:1) PRIMARY BREAST AUGMENTATION TO INCREASE BREAST SIZE; AND 2) REVISION BREAST AUGMENTATION TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST AUGMENTATION SURGERY.
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