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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMEDTRONIC, INC.
PMA NumberP010015
Supplement NumberS195
Date Received03/22/2013
Decision Date04/11/2013
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Automation of the destructive test analysis for monitored processes.
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