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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameRESPONSE CV CATHETER SYSTEM
Classification Namesystem,pacing,temporary,acute,internal atrial defibrillation
ApplicantST. JUDE MEDICAL
PMA NumberP020052
Date Received12/02/2002
Decision Date05/07/2003
Product Code
MTE[ Registered Establishments with MTE ]
Docket Number 03M-0343
Notice Date 08/26/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the response cv catheter system, which includes the following components: sjm cardioversion response (cv) electrophysiology catheter; sjm cv electrophysiology extension cable; sjm cardioversion switchbox system; and sjm cardioversion cable. This system is indicated as follows: the sjm cardioversion response (cv) electrophysiology catheter when used with the sjm cv electrophysiology extension cable and sjm switchbox system is indicated for use in the invasive evaluation of cardiac arrhythmias and can be used for intracardiac cardioversion of atrial tachyarrhythmias. The sjm cv electrophysiology extension cable is intended to connect a sjm response (cv) cardioversion electrophysiology catheter to a sjm cardioversion switchbox system. The sjm cardioversion switchbox system is intended to connect a sjm cardioversion (cv) electrophysiology catheter and sjm cv electrophysiology extension cable to a compatible cardioverter/ defibrillator and ep recording system. The sjm cardioversion cable is intended to connect the sjm cardioversion switchbox system to a compatible cardioverter.
Approval Order Approval Order
Supplements: S001 S003 S004 S005 S006 S007 S008 S009 
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