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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 ABILITY LEADS 4196, 4296 AND 4396
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Applicant MEDTRONIC INC.
PMA NumberP080006
Supplement NumberS042
Date Received08/03/2012
Decision Date08/30/2012
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Modifications to a controlled environment.
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