# P040046: Natrelle Highly Cohesive Silicone-Filled Breast Implants

- Pathway: PMA
- Applicant: Allergan
- Decided: Feb 20, 2013 after 2,998 days
- Product code: FTR (Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled)
- Device class: 3
- Regulation: 21 CFR 878.3540
- Recalls of this device: 1 (1 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.
1 of 1 device in its family (counting itself) has 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
- Jul 24, 2019 · Class I · Z-2452-2019: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in pat

Source page: https://510kreport.com/device/P040046
Methodology: https://510kreport.com/methodology