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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameRESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER
Classification Namesystem,pacing,temporary,acute,internal atrial defibrillation
Generic Namecardiac ablation catheter
ApplicantST. JUDE MEDICAL
PMA NumberP020052
Supplement NumberS004
Date Received08/24/2007
Decision Date09/21/2007
Product Code
MTE[ Registered Establishments with MTE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification of the method of tray cleaning used in packaging of the device.
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