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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 NumberS006
Date Received05/27/2010
Decision Date06/25/2010
Withdrawal Date04/17/2015
Product Code MTE 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE.
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