PMA
P970012: MEDTRONIC.KAPPA 400 SERIES PACEMAKERS
FDA PMA · Pulse generator, permanent, implantable · Medtronic, Inc.
Key facts
| PMA number | P970012 |
|---|---|
| Trade name | MEDTRONIC.KAPPA 400 SERIES PACEMAKERS |
| Generic name | Pulse generator, permanent, implantable |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | NVZ |
| Approval date | Jan 30, 1998 |
| Docket number | 98M-0231 |
| Notice date | Apr 16, 1998 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 10–99 Supplements
- Mar 20, 2025 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: