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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePIPELINE EMBOLIZATION DEVICE
Generic Nameintracranial aneurysm flow diverter
Applicant
Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR
9775 toledo way
irvine, CA 92618
PMA NumberP100018
Supplement NumberS003
Date Received08/01/2011
Decision Date08/30/2011
Product Code OUT 
Advisory Committee Neurology
Supplement Typespecial (immediate track)
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ADDING A WARNING ABOUT ALLERGIES TO METALS USED IN THE DEVICE AND CLARIFYING YOUR INSTRUCTIONS FOR UESE.
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