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March 1, 2021
Company: Medtronic Date of Enforcement Report: 3/1/2021 Class I PRODUCT HVAD Pump Implant Kits for the HeartWare HVAD System PUMP 1103 PUMP 1104 PUMP 1104JP The HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit is part of the HeartWare HVAD System, which is used to help the heart continue to pump blood to the rest...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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