PMA supplement
P890003 S048: PREVA ST DR MODEL 7078 AND THE PREVA D MODEL 7068 IMPLANTABLE PULSE GENERATORS, AND MODEL 9559 SOFTWARE
FDA PMA supplement · Normal 180 Day Track · Medtronic, Inc.
Key facts
| Original PMA | P890003 |
|---|---|
| Supplement number | S048 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | PREVA ST DR MODEL 7078 AND THE PREVA D MODEL 7068 IMPLANTABLE PULSE GENERATORS, AND MODEL 9559 SOFTWARE |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | Medtronic, Inc. |
| Product code | DXY |
| Received date | Oct 22, 1996 |
| Decision date | Nov 19, 1996 |
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: