PMA
P860008: ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7
FDA PMA · SYSTEM, ESOPHAGEAL PACING · Cardio Command
Key facts
| PMA number | P860008 |
|---|---|
| Trade name | ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7 |
| Generic name | SYSTEM, ESOPHAGEAL PACING |
| Applicant | Cardio Command |
| Owner/operator | CARDIOCOMMAND, INC. |
| Product code | LPA |
| Approval date | Dec 30, 1986 |
| Docket number | 87M-0009 |
| Notice date | Feb 25, 1987 |
| Establishment registration | 1927197 |
| FEI number | 1927197 |
At a glance
- 10–99 Supplements
- Jun 19, 2017 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: