PMA
P920032: MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER
FDA PMA · Generator, pulse, pacemaker, external programmable (for electrophysiological studies only) · Pace Medical
Key facts
| PMA number | P920032 |
|---|---|
| Trade name | MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER |
| Generic name | Generator, pulse, pacemaker, external programmable (for electrophysiological studies only) |
| Applicant | Pace Medical |
| Product code | JOQ |
| Approval date | Mar 10, 1994 |
| Docket number | 94M-0129 |
| Notice date | May 6, 1994 |
| FEI number | 1218087 |
At a glance
- 1–9 Supplements
- Feb 20, 2002 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None 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: