PMA
P870054: KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR
FDA PMA · Implantable pacemaker Pulse-generator · Cook Pacemaker Corp.
Key facts
| PMA number | P870054 |
|---|---|
| Trade name | KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | Cook Pacemaker Corp. |
| Owner/operator | COOK, INC. |
| Product code | DXY |
| Approval date | Apr 29, 1988 |
| Docket number | 88M-0187 |
| Notice date | Jun 9, 1988 |
| Establishment registration | 1820334 |
| FEI number | 1820334 |
At a glance
- 10–99 Supplements
- Jul 12, 1995 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: