PMA
P990069: ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)
FDA PMA · System, pacing, temporary, acute, internal atrial defibrillation · Dot Medical Products, Ltd.
Key facts
| PMA number | P990069 |
|---|---|
| Trade name | ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08) |
| Generic name | System, pacing, temporary, acute, internal atrial defibrillation |
| Applicant | Dot Medical Products , Ltd. |
| Owner/operator | DOT GmbH |
| Product code | MTE |
| Approval date | Nov 27, 2002 |
| Docket number | 03M-0240 |
| Notice date | Jun 24, 2003 |
| Establishment registration | 3006001176 |
| FEI number | 3014281154 |
At a glance
- 1–9 Supplements
- Sep 29, 2003 Latest supplement decision
- No Withdrawn
- Yes 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: