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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.
 
DeviceCARDIOVERSION SWITCHBOX II SYSTEM
Generic NameSystem, pacing, temporary, acute, internal atrial defibrillation
ApplicantSt Jude Medical
14901 Deveau Pl.
Minnetonka, MN 55345
PMA NumberP020052
Supplement NumberS001
Date Received07/15/2003
Decision Date08/22/2003
Withdrawal Date04/17/2015
Product Code MTE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE CARDIOVERSION SWITCHBOX II SYSTEM. THE DEVICE IS INDICATED AS FOLLOWS: THE CARDIOVERSION SWITCHBOX II SYSTEM CONNECTS A ST. JUDE MEDICAL CARDIOVERSION (CV) CATHETER AND EXTENSION CABLE TO A COMPATIBLE CARDIOVERTER/DEFIBRILLATOR AND EP RECORDING SYSTEM.
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