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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.
 
DeviceRESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER
Generic NameSystem, pacing, temporary, acute, internal atrial defibrillation
ApplicantSt Jude Medical
14901 Deveau Pl.
Minnetonka, MN 55345
PMA NumberP020052
Supplement NumberS004
Date Received08/24/2007
Decision Date09/21/2007
Withdrawal Date04/17/2015
Product Code MTE 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MODIFICATION OF THE METHOD OF TRAY CLEANING USED IN PACKAGING OF THE DEVICE.
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