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SFA ISR Investigational Plan
Document: CL001801
Revision 4.019 February 2016-Page 1 of 51A Prospective, Multi center, Single Trial of the
Nutanix Drug Coated Balloon for Treatment of
Femoropopliteal
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What is failure analysis - asm?
Failure analysis - asm is a process of investigating and determining the cause of failures in electronic assemblies.
Who is required to file failure analysis - asm?
Manufacturers or suppliers of electronic assemblies are required to file failure analysis - asm.
How to fill out failure analysis - asm?
Failure analysis - asm can be filled out by providing detailed information about the failed electronic assembly and the circumstances surrounding the failure.
What is the purpose of failure analysis - asm?
The purpose of failure analysis - asm is to identify the root cause of failures in electronic assemblies and to prevent future occurrences.
What information must be reported on failure analysis - asm?
Information such as date of failure, type of electronic assembly, symptoms of failure, and initial inspection results must be reported on failure analysis - asm.
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