PMA supplement
P880006 S007: SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B
FDA PMA supplement · Special (Immediate Track) · St. Jude Medical, Inc.
Key facts
| Original PMA | P880006 |
|---|---|
| Supplement number | S007 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | St. Jude Medical, Inc. |
| Product code | DXY |
| Received date | May 10, 1990 |
| Decision date | May 30, 1990 |
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: