PMA
P880006: SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM
FDA PMA · Implantable pacemaker Pulse-generator · St. Jude Medical, Inc.
Key facts
| PMA number | P880006 |
|---|---|
| Trade name | SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | St. Jude Medical, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | DXY |
| Approval date | Feb 28, 1989 |
| Docket number | 89M-0089 |
| Notice date | Apr 18, 1989 |
| Establishment registration | 2017865 |
| FEI number | 2017865 |
At a glance
- 10–99 Supplements
- Feb 12, 2016 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- Yes Withdrawn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: