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. |
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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 |
Supplement Number | S003 |
Date Received | 04/23/2019 |
Decision Date | 07/05/2019 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | request for adn |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an annual distribution number (adn) and the ability to make a profit. |
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