PMA supplement
P830045 S045: SIEMENS PACESETTER MODEL 3070
FDA PMA supplement · Normal 180 Day Track · St. Jude Medical, Inc.
Key facts
| Original PMA | P830045 |
|---|---|
| Supplement number | S045 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | SIEMENS PACESETTER MODEL 3070 |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | St. Jude Medical, Inc. |
| Product code | LWP |
| Received date | Jul 12, 1993 |
| Decision date | Sep 2, 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: