Regulatory Case Studies

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Perclose: 510(k) vs. PMA
Date: 7/23/2011
Length: 2 minutes
Speaker(s): Howard Holstein
Sources: Stanford Biodesign
Description: Paul Yock interviews Howard Holstein, regulatory attorney, on Regulatory Case Studies:
Question 1: Can you tell us the story of Perclose?

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Cyberonics: Overcoming Panel Recommendations
Howard Holstein
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Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on regulatory case studies:
Question 4: Is it possible to overcome the recommendations of an expert panel?
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Emphasys: Expert Panels
Howard Holstein
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Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on regulatory case studies:
Question 3: Can you give us an example of the FDA expert panels?
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Neuroretrieval Devices: Pathway Strategy
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Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on regulatory case studies
Question 2: What were the neuroretrieval devices pathway strategy? Watch More
Perclose: 510(k) vs. PMA
Howard Holstein
7/23/2011
Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on Regulatory Case Studies:
Question 1: Can you tell us the story of Perclose?
Watch More

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