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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 NumberS011
Date Received07/06/2010
Decision Date08/05/2010
Product Code OJX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
TRANSFER OF THE LASER ABLATION PROCESS, THE ADDITION OF NEW LASER ABLATION EQUIPMENT, AND CHANGES IN THE ABLATION PROCESS.
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