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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.
 
DeviceCONSULTA CRT-P, SYNCRA CRT-P
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP010015
Supplement NumberS201
Date Received05/13/2013
Decision Date07/15/2013
Product Code OJX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CELLULAR CONNECTIVITY FOR REMOTE MONITORING WITH MODEL 2020A CARDIOSIGHT READER AND MODELS 2020B, 2020C MEDTRONIC CARELINK EXPRESS MONITORS.
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