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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 Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
PMA NumberP010031
Supplement NumberS199
Date Received05/20/2010
Decision Date07/15/2010
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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).