PMA
P920011: MAXIM PFS MODEL 033-301
FDA PMA · Permanent pacemaker Electrode · St. Jude Medical, Cardiac Rhythm Management Divisi
Key facts
| PMA number | P920011 |
|---|---|
| Trade name | MAXIM PFS MODEL 033-301 |
| Generic name | Permanent pacemaker Electrode |
| Applicant | St. Jude Medical, Cardiac Rhythm Management Divisi |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | DTB |
| Approval date | Nov 7, 1996 |
| Docket number | 97M-0275 |
| Notice date | Jul 8, 1997 |
| Establishment registration | 2017865 |
| FEI number | 2017865 |
At a glance
- None Supplements
- Nov 7, 1996 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- Yes Withdrawn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: