PMA supplement
P820023 S005: PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P
FDA PMA supplement · Pacesetter Systems
Key facts
| Original PMA | P820023 |
|---|---|
| Supplement number | S005 |
| Trade name | PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Pacesetter Systems |
| Product code | LWP |
| Received date | Nov 3, 1983 |
| Decision date | Feb 23, 1984 |
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: