Puregraft Serene Breast Implant
FDA premarket approval P120011/S026 · decided 2024-03-15
Approval details
- PMA number
- P120011
- Supplement
- S026
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Puregraft Serene Breast Implant
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Bimini Health Tech
- Date received
- 2023-10-13
- Decision date
- 2024-03-15
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Approval for changing the name from IDEAL IMPLANT® Structured Breast Implant to Puregraft Serene Breast Implant.
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