# P010020: Ams Acticon Neosphincter

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: Dec 18, 2001 after 263 days
- Product code: MIP (Implanted Fecal Incontinence Device)
- Device class: 3
- 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
- May 9, 2011 · Not classified · Z-2668-2011: American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps. Based upon a review of our product test procedures, we are unable to confirm that all Control Pu

Source page: https://510kreport.com/device/P010020
Methodology: https://510kreport.com/methodology