# P990001: Diva Platform Implantable Pulse Generators and Pro Vit Application Software Version 3.3.2

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Sep 27, 1999 after 261 days
- Product code: NVZ (Pulse Generator, Permanent, Implantable)
- 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
- Feb 5, 2007 · Not classified · Z-0999-2007: Pacing rate; Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to automatic retrograde conduction testing, can inhibit the device from pacing if the patient's 

Source page: https://510kreport.com/device/P990001
Methodology: https://510kreport.com/methodology
