PMA
P840002: STAT-PACE II
FDA PMA · SYSTEM, ESOPHAGEAL PACING · Cardiocommand, Inc.
Key facts
| PMA number | P840002 |
|---|---|
| Trade name | STAT-PACE II |
| Generic name | SYSTEM, ESOPHAGEAL PACING |
| Applicant | Cardiocommand, Inc. |
| Owner/operator | CARDIOCOMMAND, INC. |
| Product code | LPA |
| Approval date | Apr 30, 1986 |
| Docket number | 86M-0237 |
| Notice date | Jul 1, 1986 |
| Establishment registration | 1927197 |
| FEI number | 1927197 |
At a glance
- 1–9 Supplements
- Mar 24, 2016 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: