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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 HDE to get an up-to-date view of this device.
 
Trade NamePK Papyrus Covered Coronary Stent System
Classification Namecoronary covered stent
Generic Namecoronary covered stent
Applicant
Biotronik AG
ackerstrasse 6
bülach 8180
HDE NumberH170004
Supplement NumberS027
Date Received04/16/2024
Decision Date05/17/2024
Product Code
NIV[ Registered Establishments with NIV ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for an additional visual inspection at biotronik ag and biotronik apm and work instruction consolidation at biotronik ag.
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