FDA To Meet With Medtronic On Drug Pump Risks; Warning Letter Sent
This article was originally published in The Gray Sheet
The agency posted a warning letter to Medtronic Aug. 21 citing the firm for multiple quality system deviations, including lapses in its efforts to address a failure risk for the SynchroMed II drug infusion pump.
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Medtronic's revenue of $7.1bn for the second fiscal quarter of 2018 was down 4% year-over-year on an as-reported basis, but up 4% on a comparable constant-currency basis. –It would have been even greater if not for the hurricane that hindered manufacturing operations in Puerto Rico, the company reported Nov 21.
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