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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received08/26/1993
Decision Date02/09/1995
Product Code
LPB[ Registered Establishments with LPB ]
Docket Number 95M-0057
Notice Date 04/28/1995
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S014 S015 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S027 S028 S029 S030 
S031 S032 S033 S034 S035 S036 S037 S038 S039 
S040 S041 S042 S043 
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