PMA
P900070: META DDDR PACING SYSTEM
FDA PMA · Implantable pacemaker Pulse-generator · St. Jude Medical, Cardiac Rhythm Management Divisi
Key facts
| PMA number | P900070 |
|---|---|
| Trade name | META DDDR PACING SYSTEM |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | St. Jude Medical, Cardiac Rhythm Management Divisi |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | DXY |
| Approval date | Jan 30, 1992 |
| Docket number | 92m-0054 |
| Notice date | Feb 24, 1992 |
| Establishment registration | 2017865 |
| FEI number | 2017865 |
At a glance
- 10–99 Supplements
- Jul 28, 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- Yes Withdrawn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: