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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 road
lake oswego, OR 97035
HDE NumberH170004
Supplement NumberS017
Date Received07/18/2022
Decision Date08/11/2022
Product Code
NIV[ Registered Establishments with NIV ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Addition of a plasma treatment step for the balloon surface of the pk papyrus delivery system prior to stent crimping.
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