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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 NameATAKR(TM) RFCA SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation
Applicant MEDTRONIC INC.
PMA NumberP930029
Supplement NumberS001
Date Received02/15/1995
Decision Date05/17/1995
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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