# P120011: Puregraft Serene Breast Implant

- Pathway: PMA
- Applicant: Bimini Health Tech
- Decided: Nov 14, 2014 after 872 days
- Product code: FWM (Prosthesis, Breast, Inflatable, Internal, Saline)
- Device class: 3
- Regulation: 21 CFR 878.3530
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Mar 18, 2019 · Class II · Z-2219-2019: The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.

Source page: https://510kreport.com/device/P120011
Methodology: https://510kreport.com/methodology