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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
ApplicantMicro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR
9775 Toledo Way
Irvine, CA 92618
PMA NumberP100018
Supplement NumberS004
Date Received09/19/2011
Decision Date03/22/2012
Product Code OUT 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT EV3 NEUROVASCULAR, IRVINE, CALIFORNIA AS AN ADDITIONAL MANUFACTURING SITE FOR THE DEVICE.
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