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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 AND THR RF MARINR NTC
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation
Applicant MEDTRONIC INC.
PMA NumberP930029
Supplement NumberS002
Date Received03/20/1995
Decision Date06/23/1995
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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