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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.
DeviceSiello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP070008
Supplement NumberS096
Date Received07/13/2018
Decision Date08/27/2018
Product Code NKE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes