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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 |
|
HDE Number | H170004 |
Supplement Number | S025 |
Date Received | 02/27/2024 |
Decision Date | 03/26/2024 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The removal of redundant in-process inspection for the stent surface. |