# P970024: Angeion Sentinel Implantable Cardioverter Defibrillator (Icd)System and the Angeflex TM Defibrillation Lead System.

- Pathway: PMA
- Applicant: MicroPort CRM USA, Inc.
- Decided: Aug 19, 1998 after 426 days
- Product code: LWS (Implantable Cardioverter Defibrillator (Non-Crt))
- Device class: 3
- Recalls of this device: 2 (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
- Jan 25, 2005 · Not classified · Z-0802-05: A change in the automatic capacitor reform schedule during the later portion of the device's useful life can result in excessive 750V charge times and disable the device's ability to report an End of 
- Jan 25, 2005 · Not classified · Z-0801-05: A change in the automatic capacitor reform schedule during the later portion of the device's useful life can result in excessive 750V charge times and disable the device's ability to report an End of 

Source page: https://510kreport.com/device/P970024
Methodology: https://510kreport.com/methodology