Pipeline Flex Embolization with Shield Technology

FDA Premarket Approval P100018 S032

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.

Pre-market Approval Supplement Details

Approval of the revised protocol for the post-approval study (pas) pipeline flex embolization w/shield tech pas. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p100018/s026.

DevicePipeline Flex Embolization with Shield Technology
Generic NameIntracranial Aneurysm Flow Diverter
ApplicantMicro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR
Date Received2021-04-30
Decision Date2021-07-19
PMAP100018
SupplementS032
Product CodeOUT 
Advisory CommitteeNeurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination Product No
Applicant Address Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR 9775 Toledo Way irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P100018Original Filing
S037 2022-08-09 Real-time Process
S036 2021-12-08 30-day Notice
S035
S034
S033 2021-07-12 30-day Notice
S032 2021-04-30 Normal 180 Day Track No User Fee
S031 2021-02-19 30-day Notice
S030 2020-11-27 30-day Notice
S029
S028 2020-08-24 Special (immediate Track)
S027 2020-06-02 30-day Notice
S026
S025
S024
S023 2019-08-22 30-day Notice
S022
S021 2019-07-05 30-day Notice
S020 2019-04-26 30-day Notice
S019 2018-11-29 30-day Notice
S018 2018-09-24 30-day Notice
S017 2017-12-15 Normal 180 Day Track No User Fee
S016 2017-09-14 30-day Notice
S015 2017-06-28 Panel Track
S014 2016-03-03 30-day Notice
S013 2014-10-06 Special (immediate Track)
S012 2014-07-21 30-day Notice
S011 2014-06-26 Normal 180 Day Track
S010 2014-01-28 30-day Notice
S009
S008 2013-07-22 Real-time Process
S007 2013-04-11 30-day Notice
S006 2013-03-12 30-day Notice
S005 2012-12-21 Special (immediate Track)
S004 2011-09-19 Normal 180 Day Track No User Fee
S003 2011-08-01 Special (immediate Track)
S002
S001 2011-04-28 Normal 180 Day Track No User Fee

NIH GUDID Devices

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