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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.
 
DeviceATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD, CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantMEDTRONIC Inc.
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP010015
Supplement NumberS290
Date Received12/28/2015
Decision Date01/25/2016
Product Code NKE 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
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