FDA released Medtronic/Physio-Control from shipping restrictions

02/22/2010

On February 19, 2010, the FDA has released Medtronic/Physio-Control from any and all shipping and manufacturing restrictions. Physio-Control is free to ship worldwide once again.

On February 19, 2010, Medtronic/Physio-Control received approval from the US Food and Drug Administration to resume unrestricted shipments. This approval comes a little over three years after Physio-Control  voluntarily suspended shipments as a result of quality system issues identified in a 2006 FDA Audit.  Since Physio-Control’s “Stop Ship” announcement in January 2007, they have been working diligently to identify deficiencies and improve all processes. Therefore, in December 2009, Physio-Control completed all of the stipulations set out in 2008 Consent Decree and extended an audit invitation to FDA. After several months of reviewing and re-reviewing all processes, the FDA confirmed Physio-Control to be in compliance and rendered a decision to lift all restrictions.  

CLICK HERE to view the letter by Brian Webster, President of Physio-Control.