St Jude Medical Fda

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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 able to get insi… See more

510(k) Premarket Notification - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163407

St. Jude Medical, Inc. 15900 Valley View Ct. Sylmar, CA 91342 Correspondent Contact: Jennifer Dunham: Regulation Number: 870.2800: Classification …

St. Jude Medical gets FDA approval for new heart-device …

https://www.startribune.com/st-jude-medical-gets-fda-approval-for-new-heart-device-technology/369141461/

St. Jude stock rose more than 2 percent to $53.15 per share Wednesday. Also Wednesday, St. Jude announced FDA approval for a …

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 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 Agrees to Pay $27 Million for Allegedly …

https://www.justice.gov/usao-md/pr/st-jude-medical-agrees-pay-27-million-allegedly-selling-defective-heart-devices

Baltimore, Maryland – 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 …

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 …

St. Jude Medical - Wikipedia

https://en.wikipedia.org/wiki/St._Jude_Medical

St. Jude Medical, Inc. was an American global medical device company headquartered in Little Canada, Minnesota, U.S., a suburb of Saint Paul. The company had more than 20 …

Insertable Cardiac Monitor Medical Device Identification

https://fda.report/GUDID/05415067040046

ST. JUDE MEDICAL, INC. FDA.report › GUDID › ST. JUDE MEDICAL, INC. ... Devices Manufactured by ST. JUDE MEDICAL, INC. 05415067034960 - NA: 2023-01-12 Clinician Programmer App: …

MAUDE Adverse Event Report: ST. JUDE MEDICAL, …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=11904812&pc=LWR

JUDE MEDICAL, BRASIL LTDA EPIC STENTED TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE Home Vaccines, Blood & Biologics Animal & Veterinary MAUDE …

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