# P970012: Medtronic.Kappa 400 Series Pacemakers

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Jan 30, 1998 after 357 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
- May 18, 2009 · Not classified · Z-1515-2009: One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry,

Source page: https://510kreport.com/device/P970012
Methodology: https://510kreport.com/methodology