PMA
P020052: RESPONSE CV CATHETER SYSTEM
FDA PMA · System, pacing, temporary, acute, internal atrial defibrillation · St Jude Medical
Key facts
| PMA number | P020052 |
|---|---|
| Trade name | RESPONSE CV CATHETER SYSTEM |
| Generic name | System, pacing, temporary, acute, internal atrial defibrillation |
| Applicant | St Jude Medical |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MTE |
| Approval date | May 7, 2003 |
| Docket number | 03M-0343 |
| Notice date | Aug 26, 2003 |
| Establishment registration | 2182269 |
| FEI number | 2182269 |
At a glance
- 1–9 Supplements
- Dec 20, 2011 Latest supplement decision
- Yes Withdrawn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: