PMA
P880038: META-MV,PACING SYSTEM
FDA PMA · Implantable pacemaker Pulse-generator · St. Jude Medical, Inc.
Key facts
| PMA number | P880038 |
|---|---|
| Trade name | META-MV,PACING SYSTEM |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | St. Jude Medical, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | DXY |
| Approval date | Apr 7, 1989 |
| Docket number | 89M-0137 |
| Notice date | May 17, 1989 |
| Establishment registration | 3012179728 |
| FEI number | 1000526851 |
At a glance
- 10–99 Supplements
- Jul 11, 2006 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- Yes Withdrawn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: