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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.
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
PMA NumberP080006
Supplement NumberS078
Date Received04/03/2015
Decision Date04/28/2015
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 
The following manufacturing changes: 1) the addition of an alternative testing system for electrode components; 2) use of factoryworks release 7. 9 manufacturing software; 3) a reduction in the exposure time during ethylene oxide half-cycle testing; 4) a reduction in the frequency of environmental monitoring testing in specific manufacturing areas; 5) an update to the maximum sterilization load profile temperature; and 6) use of factoryworks release 7. 11 manufacturing software.