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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 Stability Quad MRI Surescan
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMEDTRONIC Inc.
710 MEDTRONIC PARKWAY NE
MINNEAPOLIS, MN 55432
PMA NumberP080006
Supplement NumberS175
Date Received03/13/2023
Decision Date03/17/2023
Product Code OJX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Transfer of component extrusion lines from the Santa Rosa facility to the Medtronic Danvers facility.
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