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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 NameBARD ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namerf diagnostic/ablation catheter
ApplicantC.R. BARD, INC.
PMA NumberP000020
Supplement NumberS016
Date Received10/16/2012
Decision Date11/13/2012
Product Code
LPB[ Registered Establishments with LPB ]
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 electrical tester and barcode scanner.
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