PMA
P830045: MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S
FDA PMA · Implantable pulse generator, pacemaker (non-CRT) · St. Jude Medical, Inc.
Key facts
| PMA number | P830045 |
|---|---|
| Trade name | MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | St. Jude Medical, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LWP |
| Approval date | Mar 22, 1984 |
| Docket number | 84M-0126 |
| Notice date | Apr 20, 1984 |
| Establishment registration | 3012179728 |
| FEI number | 1000526851 |
At a glance
- 100–999 Supplements
- Oct 24, 2007 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: