|
Device | GEM VR MODELS 7227 B/D/E/CX |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P900061 |
Supplement Number | S047 |
Date Received | 09/07/2001 |
Decision Date | 10/10/2001 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE CONNECTOR MODULES AND CONNECTOR ASSEMBLY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GEM VR MODELS 7227 B/D/E/CX AND 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 A CARDIAC ARREST (MANIFESTED BY LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA 2) RECURRENT, POORLY TOLERATED, SUSTAINED VENTRICULAR TACHYCARDIA. |