PMA
P840014: DDD PULSE GENERATOR 674
FDA PMA · Implantable pulse generator, pacemaker (non-CRT) · Pacesetter Systems
Key facts
| PMA number | P840014 |
|---|---|
| Trade name | DDD PULSE GENERATOR 674 |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Pacesetter Systems |
| Product code | LWP |
| Approval date | Jul 31, 1986 |
| Docket number | 86M-0343 |
| Notice date | Sep 8, 1986 |
At a glance
- None Supplements
- Jul 31, 1986 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- No Withdrawn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: