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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.
 
DeviceALERT SYSTEM-COMPANION II
Generic NameSystem, pacing, temporary, acute, internal atrial defibrillation
ApplicantDot Medical Products , Ltd.
3 Baily Ct., Green St.
Macclesfield, Cheshire SK10 1JQ
PMA NumberP990069
Supplement NumberS001
Date Received04/28/2003
Decision Date09/29/2003
Withdrawal Date03/12/2025
Product Code MTE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ALERT SYSTEM, COMPANION II. THE DEVICE, AS MODIFIED, IS INDICATED FOR USE IN PATIENTS WHO ARE CANDIDATES FOR TRANSVENOUS ELECTRICAL CARDIOVERSION FOR THE TREATMENT OF ATRIAL FIBRILLATION.
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