PMA
P980035: MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE
FDA PMA · Pulse generator, permanent, implantable · Medtronic, Inc.
Key facts
| PMA number | P980035 |
|---|---|
| Trade name | MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE |
| Generic name | Pulse generator, permanent, implantable |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | NVZ |
| Approval date | Jan 29, 1999 |
| Docket number | 99M-2671 |
| Notice date | Aug 17, 1999 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 100–999 Supplements
- Oct 5, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: