Translational Pathways for Cardiovascular Devices – Session IV: Current Challenges and Future Direction for Coronary Stent Development and Iteration – FDA Point of Review – Michael John Practice Quiz
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Question 1 of 8
1. Question
The FDA premarket application for a coronary drug-eluting stent requires?
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Question 2 of 8
2. Question
The FDA premarket approval application for a drug-eluting stent is reviewed by:
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Question 3 of 8
3. Question
Most frequent cause of IDE disapproval is insufficient non-clinical testing?
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Question 4 of 8
4. Question
Which of the following is required for non-clinical testing of drug-eluting stents?
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Question 5 of 8
5. Question
Indication changes for an approved drug-eluting stent usually requires which of the following trial designs?
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Question 6 of 8
6. Question
Device iteration of stents is usually approved without new clinical data
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Question 7 of 8
7. Question
Which of the following trial designs would you recommend to obtain regulatory approval for a novel drug-eluting stent?
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Question 8 of 8
8. Question
All device iterations for an approved drug-eluting stent require clinical testing before they are implanted in patients?
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