Based upon your review and analysis write an “Analysis Paper” using the following information.
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1
Product Identification
 Type of product, i.e., Sirolimus-Eluting Coronary Stent and delivery system (medical device, combination product etc.),
 Classification Type (Risk Category and Controls),
 Medical Specialty Applicable for Devices Review,
 Regulatory Approval Pathway (PMA, i.e., why the device was approved under this category),
 Applicable CFR for approval (Why the specific CFR was applicable),
 Applicable Product Classification Code.
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2
FDA Approval Summary
 Review FDA approval history,
 Summary for Safety and Effectiveness,
 Advisory Committee (if applicable),
 Combination Product (Yes/No),
 Clinical Trials (use the Clinicals Trials Database).

Clinical Trials Database
Review the Clinical Trials Database using the Product Name. Using following link : clinicaltrials.gov

In the analysis include the following areas:
o Explain the type of product and write its description (include all details/criterion provided above)
o What are the challenges in developing such a medical device category (therapy, clinical use, product development)?
o What type of safety issues could apply to the use of this medical device?
o What are the applicable risks for this product (i.e., intended clinical use, procedure, patient outcome)?
o Are there any similarly marketed products in this medical category (i.e., similar to this subject medical device?
o Add the latest information about current market trends in this medical device category.

Sample Solution