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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 ABILITY LEAD
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMEDTRONIC Inc.
710 MEDTRONIC PARKWAY NE
MINNEAPOLIS, MN 55432
PMA NumberP080006
Supplement NumberS058
Date Received09/30/2013
Decision Date10/17/2013
Product Code OJX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
UPDATE TO THE MANUFACTURING AND INSPECTION PROCESS FOR TUBING USED IN MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
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