April 21 (Reuters) - St Jude Medical Inc:
* Says received a warning letter from FDA related to its atrial fibrillation
division manufacturing facility in Minnetonka, minnesota
* Saus FDA issued a form 483 identifying certain observed non-conformity with
current good manufacturing practice primarily related to the manufacture and
assembly of the safire ablation catheter
* Says the FDA letter notes that it will not grant requests for exportation
certificates to foreign governments or approve pre-market approval
applications for class III devices until violations are corrected
* Says FDA warning letter acknowledges actions already taken by St Jude.
medical's af division to address the observations
((New York Equities Desk; tel: +1 646 223 6000))
(For more news about St Jude Medical Inc click here:) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
* Says received a warning letter from FDA related to its atrial fibrillation
division manufacturing facility in Minnetonka, minnesota
* Saus FDA issued a form 483 identifying certain observed non-conformity with
current good manufacturing practice primarily related to the manufacture and
assembly of the safire ablation catheter
* Says the FDA letter notes that it will not grant requests for exportation
certificates to foreign governments or approve pre-market approval
applications for class III devices until violations are corrected
* Says FDA warning letter acknowledges actions already taken by St Jude.
medical's af division to address the observations
((New York Equities Desk; tel: +1 646 223 6000))
(For more news about St Jude Medical Inc click here:) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.