What type of device? Are you looking at a TAVR or an IPG for instance?
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Michael Nilo
Network Regulatory Partners
Nilo Medical Consulting Group
Portland OR
United States
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Original Message:
Sent: 25-Jul-2017 14:23
From: Karen Bannick
Subject: fatigue cycles for cardiac device
Does anyone know the what FDA guidance document spells out how many test fatigue cycles a cardiac device must survive?
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Karen Bannick MA, RAC, FRAPS
Principal & Founder
Bannick Consulting LLC
karen@bannickconsulting.com
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