PMA
P970024: ANGEION SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)SYSTEM AND THE ANGEFLEX TM DEFIBRILLATION LEAD SYSTEM.
FDA PMA · Implantable cardioverter defibrillator (non-CRT) · MicroPort CRM USA, Inc.
Key facts
| PMA number | P970024 |
|---|---|
| Trade name | ANGEION SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)SYSTEM AND THE ANGEFLEX TM DEFIBRILLATION LEAD SYSTEM. |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | MicroPort CRM USA, Inc. |
| Owner/operator | MicroPort CRM USA, Inc. |
| Product code | LWS |
| Approval date | Aug 19, 1998 |
| Docket number | 99M-1981 |
| Establishment registration | 3009660953 |
| FEI number | 3009660953 |
At a glance
- 1–9 Supplements
- Feb 6, 2001 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- Yes Withdrawn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: