PMA
P150035: Aveir VR Leadless System
FDA PMA · Leadless pacemaker · ABBOTT MEDICAL
Key facts
| PMA number | P150035 |
|---|---|
| Trade name | Aveir VR Leadless System |
| Generic name | Leadless pacemaker |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | PNJ |
| Approval date | Mar 31, 2022 |
| Docket number | 22M-0502 |
| Notice date | Apr 1, 2022 |
| Establishment registration | 2017865 |
| FEI number | 2017865 |
At a glance
- 10–99 Supplements
- Aug 27, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: