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.
Contact HeartSafe America today to order all of your Medtronic/Physio-Control products.
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.
Contact HeartSafe America today to order all of your Medtronic/Physio-Control products.
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