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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
Generic Namedrug eluting permanent left ventricular (lv) pacemaker electrode
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP010015
Supplement NumberS087
Date Received05/20/2010
Decision Date07/15/2010
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for an update to component planting specification titled ¿material, planting, and surface finish requirements for terminals for laser ribbon-bonding (lrb), wirebonding (wb), and parallel gap welding (pgw). ¿ (revision o).