PMA supplement
P870054 S014: KELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS.
FDA PMA supplement · Normal 180 Day Track · Cook Pacemaker Corp.
Key facts
| Original PMA | P870054 |
|---|---|
| Supplement number | S014 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | KELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS. |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | Cook Pacemaker Corp. |
| Product code | DXY |
| Received date | Jun 8, 1995 |
| Decision date | Jul 12, 1995 |
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: