PMA supplement
P820018 S056: MODEL 5603,9600 PROGRAMMER NEW SOFTWARE,V4.10UE
FDA PMA supplement · Normal 180 Day Track · St. Jude Medical, Inc.
Key facts
| Original PMA | P820018 |
|---|---|
| Supplement number | S056 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | MODEL 5603,9600 PROGRAMMER NEW SOFTWARE,V4.10UE |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | St. Jude Medical, Inc. |
| Product code | LWP |
| Received date | Jun 19, 1992 |
| Decision date | Feb 5, 1993 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: