Puregraft Serene Breast Implant, IDEAL IMPLANT Structured Breast Implant
FDA premarket approval P120011/S028 · decided 2025-02-11
Approval details
- PMA number
- P120011
- Supplement
- S028
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Puregraft Serene Breast Implant, IDEAL IMPLANT Structured Breast Implant
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Bimini Health Tech
- Date received
- 2024-08-16
- Decision date
- 2025-02-11
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Approval to update the Instructions for Use and the Patient Information Booklet that were previously reviewed under P120011/S025
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