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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 & ATTAIN PERFORMA LEAD
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMedtronic, Inc.
710 Medtronic Pkwy. NE
Minneapolis, MN 55432
PMA NumberP080006
Supplement NumberS104
Date Received11/28/2016
Decision Date12/19/2016
Product Code OJX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Updates to the inspection procedure for Titanium Dioxide containing pigment paste to allow usage of a new test method.
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