Puregraft Serene Breast Implant
FDA premarket approval P120011/S025 · decided 2024-08-16
Approval details
- PMA number
- P120011
- Supplement
- S025
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Puregraft Serene Breast Implant
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Bimini Health Tech
- Date received
- 2023-02-08
- Decision date
- 2024-08-16
- Days to decision
- 555 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Solana Beach, CA
- Statement
- Approval for updated Instructions for Use and Patient Information Booklet
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.