|
Device | 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. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P970024 |
Date Received | 06/19/1997 |
Decision Date | 08/19/1998 |
Withdrawal Date
|
10/03/2022 |
Product Code |
LWS |
Docket Number | 99M-1981 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement The device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: 1) Survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; and 2) Recurrnet, poolrly tolerated, sustained ventricular tachyarrhythmia. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S001 S002 S003 S004 |