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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 NumberS034
Date Received01/28/2025
Decision Date04/11/2025
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 
The introduction of an additional wire position control and movability check during the guidewire exit port (gep) welding and cutting manufacturing steps for the pk papyrus covered coronary stent system and the orsiro mission sirolimus eluting coronary stent system.
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