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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.
 
DeviceINSYNC CRT-P, INSYNC III CRT-P, ATTAIN OTW LEAD, ATTAIN BIPOLAR OTW LEAD, ATTAIN CS LEAD AND ATTAIN LV LEAD
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP010015
Supplement NumberS073
Date Received10/08/2009
Decision Date01/21/2010
Product Code OJX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
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