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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.
 
DeviceCARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL 2020A, AND MODEL 2491 DDMA
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS262
Date Received09/26/2012
Decision Date02/08/2013
Product Code NVZ 
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  
ADDITIONAL IN-PROCESS INSPECTION OF THE HYBRID CATHODE MIX RATIO, NEW PRESSURE TEST EQUIPMENT, NEW MANUFACTURING LINES IN AN EXTENDED CONTROLLED ENVIRONMENT AREA,CMOS PROCESS FLOW CHANGES, AN UPDATE TO TEST SOFTWARE AND HARDWARE FOR INTEGRATED CIRCUITS, THE IMPLEMENTATION OF FACTORYWORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1, ANDUPDATES TO THE IC WAFER PROBE TEST SPECIFICATIONS AND TEST SOFTWARE.
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