|
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 |
Supplement Number | S001 |
Date Received | 10/03/2018 |
Decision Date | 04/05/2019 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement To introduce a supplier change for the elast-eon material used to manufacture the electrospun cover. |