Search Results for St. Jude Medical

Showing 1 – 5

FDA Warns Abbott Device Manufacturing Plant in California By Zachary Brennan - Published 13 April 2017

The warning letter sent Wednesday from the US Food and Drug Administration (FDA) details four observations on failures related to corrective and preventive actions (CAPAs), controls, design verification and design validation.

Categories: News, US, FDA, Due Diligence, Medical Devices, Quality

Tags: warning letter, Abbott, St. Jude Medical, ICDs, CRT-Ds

FDA, DHS Find Cybersecurity Vulnerabilities in St. Jude Heart Devices By Michael Mezher - Published 11 January 2017

The US Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory on Monday warning of cybersecurity vulnerabilities found in St. Jude Medical's Merlin@home wireless transmitter that could affect the company's line of implantable cardiac devices (ICDs).

Categories: News, US, FDA, Medical Devices, Postmarket surveillance

Tags: Cybersecurity, Medical Device Cybersecurity, St. Jude Medical, MedSec, Muddy Waters Research, Merlin@home Transmitter

FDA Approves First PFO Occluder From St. Jude By Zachary Brennan - Published 28 October 2016

The US Food and Drug Administration (FDA) on Friday approved Minnesota-based St. Jude Medical’s Amplatzer PFO Occluder, which is intended to reduce the risk of a stroke for some patients who previously had a stroke.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: PFO Occluder, St. Jude Medical, FDA device approval

FDA to Keep Device Advisory Committee Chair Despite Conflict of Interest By Zachary Brennan - Published 09 May 2016

The US Food and Drug Administration (FDA) has granted a waiver to allow the chairman of its Circulatory System Devices advisory panel to keep his position later this month despite a conflict of interest.

Categories: News, US, CDRH, Clinical, Crisis management, Medical Devices, Regulatory intelligence

Tags: medical device panel, St. Jude Medical, Amplatzer, PFO Occluder, FDA advisory committee, conflict of interest

Report: FDA Developing UDI Barcode System for Medical Devices By Alexander Gaffney - Published 26 April 2012

Categories: FDA, CDRH

Tags: St. Jude Medical, Medtronic, UDI, UID, OMB, Latest News, Boston scientific, medical device