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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, Inc.
6024 jean rd.
lake oswego, OR 97035
HDE NumberH170004
Supplement NumberS036
Date Received06/05/2025
Decision Date10/10/2025
Product Code
NIV[ Registered Establishments with NIV ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for an alternative manufacturing site for the coating process of a catheter component.
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