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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.
 
DeviceATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD, SYNCRA CRT-P
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Generic Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Applicant
MEDTRONIC Inc.
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP010015
Supplement NumberS197
Date Received04/10/2013
Decision Date12/24/2013
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a re-packaging/re-labeling site located at medtronic in memphis, tennesee.
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