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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 Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology
Generic NameIntracranial aneurysm flow diverter
ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
PMA NumberP100018
Supplement NumberS033
Date Received07/12/2021
Decision Date07/27/2021
Product Code OUT 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Modifications to hypotube tensile strength test of Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology, using an in-process manufacturing acceptance criteria of >= 3.0 N for the test, and shifting the hypotube tensile strength test from the final inspection step to an earlier subassembly step.
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