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March 18, 2013
09:11 EDTNUVANuVasive says received FDA warning letter related to San Diego facility
On March 13, NuVasive received a warning letter dated March 12 from the FDA related to an inspection of the company’s San Diego, California facility that occurred from October 29, 2012 through November 2, 2012. The inspection did not result in any 483 observations and the warning letter does not cite any quality system concerns.The FDA letter identifies specific labeling claims related to the company’s ILIF procedure, indicating that one of the indications noted is not cleared through any of the company’s Affix Spinous Process Plate system 510(k)s. The letter only relates to this promotional claim and the company does not anticipate a disruption in the distribution of these products. The company takes this matter seriously and has already begun to respond to the FDA’s requests. The company is giving the matter the highest priority in order to fully address the FDA’s concerns to our mutual satisfaction. As this is an administrative process to address the warning letter, the company believes the FDA’s concerns can be resolved without an impact on the company’s financial results or operations. Comments taken from an 8-K filing.
News For NUVA From The Last 14 Days
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January 14, 2015
07:37 EDTNUVAJPMorgan to hold a conference
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January 13, 2015
10:00 EDTNUVAOn The Fly: Analyst Downgrade Summary
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08:12 EDTNUVANuVasive downgraded to Neutral from Buy at Summer Street
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07:28 EDTNUVANuVasive price target raised to $55 from $50 at RW Baird
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January 12, 2015
16:06 EDTNUVANuVasive COO Valentine to step down, Miles named as successor
NuVasive announced changes to its leadership team designed to enhance the company's organizational alignment. Pat Miles, NuVasive's current President of Global Products and Services, will assume an expanded role as President and Chief Operating Officer. The company also announced that NuVasive's COO Keith Valentine will step down from that role and be leaving the company effective April 30. Valentine is committed to working with the company to ensure a seamless transition of responsibilities over the coming months, the company said.
16:04 EDTNUVANuVasive sees Q4 revenue $203M, consensus $199.95M
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16:04 EDTNUVANuVasive sees FY15 revenue $810M, consensus $811.7M
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16:02 EDTNUVANuVasive sees FY14 revenue $761M, consensus $758.16M
NuVasive provided a business and financial performance update, including the announcement of select preliminary unaudited financial results for FY14. The company sees preliminary FY14 revenue of approximately $761M, which reflects 11% growth over the prior year or 12% on a constant currency basis. Preliminary FY14 non-GAAP operating margin is anticipated to exceed guidance of 16.5%.

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