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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 |
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HDE Number | H170004 |
Date Received | 09/20/2017 |
Decision Date | 09/14/2018 |
Product Code | |
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 |