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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 Lead
Generic Namedrug eluting permanent left ventricular (lv) pacemaker electrode
710 medtronic parkway ne
minneapolis, MN 55432
PMA NumberP080006
Supplement NumberS129
Date Received10/26/2018
Decision Date04/10/2019
Product Code OJX 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the Attain Stability Quad MRI SureScan Model 4798 left ventricular (LV) lead.