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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received09/20/2017
Decision Date09/14/2018
Product Code
NIV[ Registered Establishments with NIV ]
Docket Number 18M-3505
Notice Date 09/17/2018
Advisory Committee Cardiovascular
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
This device is indicated for the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2. 5 to 5. 0 mm in diameter.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S010 
S012 S013 S014 S015 S016 S017 S018 S019 S020 
S021 S022 S023 S025 S026 
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