PMA supplement
P920032 S004: MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER
FDA PMA supplement · Normal 180 Day Track · Pace Medical
Key facts
| Original PMA | P920032 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| 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 |
| Received date | Jan 30, 1998 |
| Decision date | Feb 27, 1998 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: