Guidant Corp.

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• Focus on the World Carotid Stents Market.

  - 2008-03-27

  LONDON, UNITED KINGDOM, Mar 27, 2008 Marketwire via COMTEX -- Reportlinker.com announces that a new market research report related to the Medical devices industry is available in its catalogue. World Carotid Stents Market This report analyzes the worldwide markets for Carotid Stents...

  Tags: Boston Scientific Corp., Consumer Electronics Association, Europe, FDA, Government, Guidant Corp., Handhelds, HARDWARE, Johnson & Johnson, Medtronic Inc., SOFTWARE, U.S.

• MedTech conference to focus on regulatory affairs

  - 2007-09-07

  SKANEATELES - Developing a new product is hard enough. Add strict oversight and regulations from the federal government and it's easy to get lost in the process, says Jane Metcalf, vice president of corporate and regulatory affairs at Conmed (NASDAQ: CNMD), a medical-device manufacturer based in Utica. MedTech, an upstate...

  Tags: FDA, Guidant Corp., Welch Allyn Inc.

• Guidant Initiates Voluntary Worldwide Physician Communication Regarding Implantable Cardiac Defibrillators

  - 2006-03-13

  INDIANAPOLIS -- Guidant Corporation (NYSE:GDT) said today it is voluntarily advising physicians about important product information regarding CONTAK RENEWAL 3 RF and RENEWAL 4 RF devices. Guidant has apprised the United States Food and Drug Administration FDA of this action and the FDA may classify this communication action as a...

  Tags: FDA, Guidant Corp.

• Guidant Announces Completion of FDA Inspection of St. Paul Facilities; Company Reports One Inspection Observation and Reiterates Anticipated Readiness for Mid-Year Re-Inspection

  - 2006-02-23

  INDIANAPOLIS -- Guidant Corporation (NYSE:GDT) announced today that the U.S. Food and Drug Administration FDA has completed an inspection of Guidant's Cardiac Rhythm Management facilities in St. Paul, Minnesota, and has provided Guidant a Form FDA-483, noting one inspection observation. The inspection was initiated on December 15, 2005, and concluded...

  Tags: FDA, Guidant Corp.

• Guidant Announces Preliminary, Unaudited 2005 Fourth Quarter Sales; Guidant Receives Anticipated FDA Follow-up Letter; No New Observations Cited

  - 2006-01-10

  INDIANAPOLIS -- Guidant Corporation (NYSE:GDT) today announced that management believes preliminary, unaudited fourth quarter sales will be approximately $828 million, reflecting a decline of approximately 15 percent versus the fourth quarter of 2004. Preliminary, unaudited U.S. and worldwide implantable defibrillator sales for the quarter are expected to be approximately $272...

  Tags: FDA, Guidant Corp.

• Guidant gets FDA warning letter on facility.

  - 2005-12-28

  M2 PRESSWIRE-28 December 2005-SessionsIR.com: Guidant gets FDA warning letter on facilityC1994-2005 M2 COMMUNICATIONS LTD RDATE:28122005 Stocks in the News: Guidant Corporation (NYSE: GDT), Repligen Corporation (NASDAQ: RGEN), CalbaTech Incorporated, Aspreva Pharmaceuticals Corporation (NASDAQ: ASPV) For Corporate or Company...

  Tags: Company, FDA, Government, Guidant Corp., Nasdaq Stock Market Inc., stem-cell

• Guidant Announces FDA Warning Letter Related to Prior FDA Inspection of St. Paul Facility; Company Will Promptly and Fully Respond to FDA

  - 2005-12-27

  INDIANAPOLIS -- Guidant Corporation (NYSE:GDT) announced today that it has received a warning letter from the U.S. Food and Drug Administration FDA related to the FDA's inspection of Guidant's Cardiac Rhythm Management facility in St. Paul, Minn. The FDA inspection was completed on September 1, 2005 and resulted in Form...

  Tags: FDA, Guidant Corp.

• Guidant Publishes Responses to U.S. Food and Drug Administration Form 483 Observations; Transcript Now Available on Company Website

  - 2005-10-27

  INDIANAPOLIS -- Guidant Corporation (NYSE:GDT) announced today that the Company has published its responses to the Form 483 observations issued by the U.S. Food and Drug Administration FDA. Guidant's responses address specific observations and detail broader steps that the Company intends to take to further enhance its Quality System. In...

  Tags: Company, FDA, Guidant Corp., Web site

• Guidant Announces Completion of FDA Inspection of St. Paul Facilities and Responds to FDA's Observations; Company Continues to Work with Stakeholders to Establish Industry Standards for Communicating Device Performance

  - 2005-09-22

  INDIANAPOLIS -- Guidant (NYSE:GDT) announced today that the U.S. Food and Drug Administration FDA has completed its inspection of Guidant's Cardiac Rhythm Management facilities in St. Paul, Minnesota, and has provided Guidant a Form 483, noting several observations of non-compliance, including an observation with commentary on two specific trends in...

  Tags: FDA, Guidant Corp., industry standard, performance

• Guidant Announces FDA Approval of Wireless Home Patient Management System; Innovative Technology Directed Toward Compliance in Heart Failure Patients at Risk of Sudden Cardiac Death

  - 2005-09-19

  INDIANAPOLIS & ST. PAUL, Minn. -- Guidant Corporation (NYSE:GDT) today announced U.S. Food and Drug Administration FDA approval of the LATITUDER Communicator, and secure data storage system. These elements represent the final components of the LATITUDE Patient Management system, which presently can be used with the CONTAK RENEWALR 3RF cardiac...

  Tags: compliance, FDA, Guidant Corp., patient, wireless