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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSWIFT(TM) 1CT SERIES 4040 DEFIBRILLATION LEAD
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP980049
Supplement NumberS008
Date Received04/15/2002
Decision Date02/14/2003
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A DEFIBRILLATION LEAD PREVIOUSLY APPROVED FOR MANUFACTURE BY ANGEION UNDER THE TRADE NAME ANGEPASS. THE LEAD IS NOW BEING MANUFACTURED BY ELA MEDICAL, S.A. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SWIFT 1CT 4040 SERIES LEAD AND IS INDICATED FOR USE WITH AN ELA MEDICAL ICD 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; 2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYARRHYTHMIA.
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