St Jude Medical Fda Warning

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Abbott (formally known as “St. Jude Medical”) Recalls …

https://www.fda.gov/medical-devices/medical-device-recalls/abbott-formally-known-st-jude-medical-recalls-assuritytm-and-enduritytm-pacemakers-potential

Abbott (formally known as “St. Jude Medical”) is recalling a subset of Assurity and Endurity pacemakers built using specific manufacturing equipment, that were then distributed from April 2015 to February 2019. A small number of devices from that time frame have experienced problems when moisture is … See more

St. Jude Medical Inc. (St. Jude) has agreed to pay $27 …

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/st-jude-agrees-pay-27-million-allegedly-selling-defective-heart-devices

St. Jude Medical Inc. (St. Jude) has agreed to pay $27 million to settle allegations under the False Claims Act that, between November 2014 and October 2016, …

Abbott (St Jude Medical Inc.) - 519686 - 04/12/2017 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/abbott-st-jude-medical-inc-519686-04122017

Abbott (St Jude Medical Inc.) - 519686 - 04/12/2017 | FDA WARNING LETTER Abbott (St Jude Medical Inc.) MARCS-CMS 519686 — April 12, 2017 Recipient: Abbott (St Jude …

FDA threatens action against medical device-maker over poor ...

https://thehill.com/policy/cybersecurity/328752-fda-threatens-st-jude-medical-devices-over-poor-cybersecurity/

The Food and Drug Administration (FDA) is threatening action if Abbott Labs fails to address safety and security issues in certain medical devices. The company recently purchased …

FDA Warns on Abbott's St. Jude Pacemakers and …

https://www.foxbusiness.com/features/fda-warns-on-abbotts-st-jude-pacemakers-and-defibrillators

The FDA's made the criticisms in a warning letter sent to Abbott on Wednesday, following an inspection of the medical-device maker's facilities in Sylmar, …

FDA sends St. Jude warning later over Calif. plant - Yahoo! News

https://news.yahoo.com/fda-sends-st-jude-warning-212931180.html

WASHINGTON (AP) -- Medical device maker St. Jude Medical said Monday it received a warning letter from the Food and Drug Administration about manufacturing …

St. Jude Medical (CardioMEMS) - 480398 - 10/17/2018

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/st-jude-medical-cardiomems-480398-10172018

United States (407) 475-4700 Dear Mr. Piplani: The Food and Drug Administration has completed an evaluation of your ftrm's corrective actions in response …

FDA warns St. Jude Medical - Star Tribune

https://www.startribune.com/fda-warns-st-jude-medical/186820021/

The U.S. Food and Drug Administration has sent a warning letter to St. Jude Medical regarding manufacturing processes at a facility in Southern California, St. Jude …

St. Jude Medical FOIA Documents | FDA

https://www.fda.gov/about-fda/ora-foia-electronic-reading-room/st-jude-medical-foia-documents

St. Jude Medical FOIA Documents | FDA St. Jude Medical FOIA Documents St. Jude Medical IESD, Sylmar, CA, Warning Letter Response dated 3/15/2013 St Jude Medical …

St. Jude Medical Settles FDA Warnings Letter for Texas Plant

https://finance.yahoo.com/news/st-jude-medical-settles-fda-162003415.html

St. Jude Medical Inc. ( STJ) revealed that U.S. Food and Drug Administration (:FDA) notified that the company has addressed issues cited in the …

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