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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.
 
DeviceALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)
Classification Namesystem,pacing,temporary,acute,internal atrial defibrillation
Generic Namesystem,pacing,temporary,acute,internal atrial defibrillation
Applicant
DOT MEDICAL PRODUCTS LTD.
3 baily court, green street
macclesfield, cheshire SK10
PMA NumberP990069
Date Received11/01/1999
Decision Date11/27/2002
Product Code
MTE[ Registered Establishments with MTE ]
Docket Number 03M-0240
Notice Date 06/24/2003
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the alert system (alert catheter, alert interface cable, and alert companion with software version 1. 08). The alert system is indicated for use in patients who are candidates for transvenous electrical cardioversion for the treatment of atrial fibrillation.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 
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