PMA
P880086: ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS
FDA PMA · Implantable pacemaker Pulse-generator · ABBOTT MEDICAL
Key facts
| PMA number | P880086 |
|---|---|
| Trade name | ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | DXY |
| Approval date | Aug 21, 1989 |
| Docket number | 89M-0363 |
| Notice date | Sep 13, 1989 |
| Establishment registration | 2017865 |
| FEI number | 2017865 |
At a glance
- 100–999 Supplements
- Jul 21, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 100–999 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: