PMA
P820023: PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P
FDA PMA · Implantable pulse generator, pacemaker (non-CRT) · Pacesetter Systems
Key facts
| PMA number | P820023 |
|---|---|
| Trade name | PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Pacesetter Systems |
| Product code | LWP |
| Approval date | Feb 4, 1983 |
| Docket number | 83M-0048 |
| Notice date | Feb 25, 1983 |
At a glance
- 1–9 Supplements
- Feb 23, 1984 Latest supplement decision
- Yes Withdrawn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: