# P940031: Vigor (TM) DR Pacemaker System

- Pathway: PMA
- Applicant: Boston Scientific
- Decided: Jun 21, 1995 after 264 days
- Product code: DXY (Implantable Pacemaker Pulse-Generator)
- Device class: 3
- Regulation: 21 CFR 870.3610
- Recalls of this device: 8 (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
- Jul 18, 2005 · Not classified · Z-1032-05: A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service lif
- Jul 18, 2005 · Not classified · Z-1033-05: A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service lif
- Jul 18, 2005 · Not classified · Z-1034-05: A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service lif
- Jul 18, 2005 · Not classified · Z-1039-05: A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service lif
- Jul 18, 2005 · Not classified · Z-1038-05: A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service lif
- Jul 18, 2005 · Not classified · Z-1036-05: A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service lif
- Jul 18, 2005 · Not classified · Z-1035-05: A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service lif
- Jul 18, 2005 · Not classified · Z-1037-05: A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service lif

Source page: https://510kreport.com/device/P940031
Methodology: https://510kreport.com/methodology