PMA
P890003: SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071
FDA PMA · Pulse generator, permanent, implantable · Medtronic, Inc.
Key facts
| PMA number | P890003 |
|---|---|
| Trade name | SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 |
| Generic name | Pulse generator, permanent, implantable |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | NVZ |
| Approval date | Aug 24, 1989 |
| Docket number | 89M-0369 |
| Notice date | Sep 19, 1989 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 100–999 Supplements
- Jul 31, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 100–999 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: