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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
    Your firm’s response should be comprehensive and address all violations included in this Warning Letter. Your response should be sent to: Food and Drug Administration, Center …

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

    Warning Letters | FDA - U.S. Food and Drug Administration

      https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
      Learn about the types of warning letters on FDA's website. Matters described …

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

    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 IESD, Sylmar, CA, Warning Letter Response Dated 2/4/2013 St Jude Medical IESD, Sylmar, CA, 483 Response Update Dated 12/7/2012 St. Jude Medical …

    Warning Letters and Notice of Violation Letters to …

      https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice-violation-letters-pharmaceutical-companies
      Warning Letters: All letters are sortable by issuing office/Center. RESOURCES Untitled Letters 2021 These letters are supplied by the CDER Freedom of Information Office and …

    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, …

    ST. JUDE MEDICAL' IIIJIIII MORE CONTROL lESS …

      https://www.fda.gov/media/85385/download
      St. Jude Medical Implantable Electronic Systems Division 15900 Valley View Court Sylmar, CA 91342-3577 USA Tel 818 362 6822 800 423 5611 February 4, 2013 …

    FDA Releases St. Jude Warning Letter

      https://www.forbes.com/sites/larryhusten/2013/01/16/fda-releases-st-jude-warning-letter/
      The FDA on Tuesday released the full text of a warning letter sent last week to St. Jude Medical. The company had previously disclosed the existence of the …

    St. Jude Medical seesaws on FDA warning letter - MassDevice

      https://www.massdevice.com/st-jude-medical-seesaws-fda-warning-letter/
      A warning letter from the FDA to St. Jude Medical (NYSE: STJ) sent the St. Paul, Minn.-based medical device company’s stock on a seesaw ride yesterday and …



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