Humanitarian Device Exemption (HDE)

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 Name: PK Papyrus Covered Coronary Stent System
• Classification Name: coronary covered stent
• Generic Name: coronary covered stent
• Applicant: BIOTRONIK, Inc.; 6024 jean road; lake oswego, OR 97035
• HDE Number: H170004
• Date Received: 09/20/2017
• Decision Date: 09/14/2018
• Product Code: NIV [ Registered Establishments with NIV ]
• Docket Number: 18M-3505
• Notice Date: 09/17/2018
• Advisory Committee: Cardiovascular
• Supplement Type: hde original
• Expedited Review Granted?: No
• Combination Product: No

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 S024 S025 S026 S027 S028 S029 ; S030 S032 S033 S034