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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 & SYSTEM ACCESSORY EQUIPMENT
Generic NameSystem, pacing, temporary, acute, internal atrial defibrillation
ApplicantSt. Jude Medical
14901 DEVEAU PLACE
MINNEAPOLIS, MN 55345-2126
PMA NumberP020052
Supplement NumberS008
Date Received09/15/2011
Decision Date10/13/2011
Withdrawal Date 04/17/2015
Product Code MTE 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ELIMINATE THE UV POST TRIM PROCESS.
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