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. |
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Device | SWIFT(TM) 1CT SERIES 4040 DEFIBRILLATION LEAD |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S008 |
Date Received | 04/15/2002 |
Decision Date | 02/14/2003 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
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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