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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 NameCARDIAC ABLATION PERCUTANEOUS CATHETER
Classification Namecardiac ablation percutaneous catheter
Applicant MEDTRONIC INC.
PMA NumberP020045
Supplement NumberS037
Date Received03/25/2011
Decision Date07/15/2011
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for sterilization and packaging changes.
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