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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
Classification Namesystem,pacing,temporary,acute,internal atrial defibrillation
Generic Namecardiac ablation catheter
ApplicantST. JUDE MEDICAL
PMA NumberP020052
Supplement NumberS007
Date Received10/07/2010
Decision Date11/05/2010
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 
Changes to the wire-to-ring and anchor wire brazing process.
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