PMA
P820018: AUTIMA(TM) MODEL 2251 & MODEL 2600
FDA PMA · Implantable pulse generator, pacemaker (non-CRT) · St. Jude Medical, Inc.
Key facts
| PMA number | P820018 |
|---|---|
| Trade name | AUTIMA(TM) MODEL 2251 & MODEL 2600 |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | St. Jude Medical, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LWP |
| Approval date | Feb 10, 1983 |
| Docket number | 83M-0055 |
| Notice date | Mar 11, 1983 |
| Establishment registration | 3012179728 |
| FEI number | 3008308852 |
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- Yes Withdrawn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: