J&J's DePuy to stop selling all custom devices in response to FDA warning
January 19, 2012 by MassDevice staff
Johnson & Johnson subsidiary Depuy Orthopaedics decides to stop selling all custom devices following an FDA letter warning the company to file new PMA and 510(k) applications for several components.
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics decided to stop selling all custom fitted devices in response to an FDA warning following an inspection of the Warsaw, Ind.-based company's facilities.
This week the FDA's Centers for Devices & Radiological Health released a letter warning Depuy that certain custom devices and components sold by the company need new PMA or 510(k) applications.
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