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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 OTW MODEL 4193
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP010015
Supplement NumberS003
Date Received11/19/2001
Decision Date05/02/2002
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ATTAIN OTW 4193 LEFT VENTRICULAR PACING LEAD. THE MODEL 4193 IS INDICATED FOR USE AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM.
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