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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
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Applicant MEDTRONIC INC.
PMA NumberP080006
Supplement NumberS041
Date Received06/11/2012
Decision Date07/11/2012
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 
Update the drug component and finished lead specification of the attain ability family of leads and the addition of an alternate testing laboratory an alternate analytical methods.
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