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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceATAKR RADIO FREQUENCY (RF) CATHETER ABLATION SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP930029
Supplement NumberS050
Date Received03/27/2015
Decision Date04/02/2015
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ACCEPTANCE OF A NEW DOSIMETRY SYSTEM AT THE LIBERTYVILLE, IL LOCATION.
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