Woven EndoBridge (WEB) Aneurysm Embolization System

Intrasaccular Flow Disruption Device

FDA Premarket Approval P170032

Pre-market Approval Supplement Details

Approval for use in adults to embolize saccular intracranial wide neck bifurcation aneurysms located in the anterior (middle cerebral artery (mca) bifurcation, internal carotid artery (ica) terminus, anterior communicating artery (acomm) complex) and posterior (basilar apex) circulations, ranging in size from 3 mm to 10 mm in dome diameter, where the neck size is 4 mm or greater or the dome-to-neck ratio is greater than 1 and less than 2.

DeviceWoven EndoBridge (WEB) Aneurysm Embolization System
Classification NameIntrasaccular Flow Disruption Device
Generic NameIntrasaccular Flow Disruption Device
ApplicantSequent Medical, Inc
Date Received2017-09-28
Decision Date2018-12-31
Notice Date2019-01-28
PMAP170032
SupplementS
Product CodeOPR
Docket Number19M-0027
Advisory CommitteeNeurology
Expedited ReviewNo
Combination Product No
Applicant Address Sequent Medical, Inc 11 A Columbia aliso Viejo, CA 92656
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P170032Original Filing
S011 2021-12-20 30-day Notice
S010 2021-11-22 30-day Notice
S009 2021-07-26 Real-time Process
S008 2021-05-06 30-day Notice
S007
S006 2020-04-06 30-day Notice
S005 2019-12-26 30-day Notice
S004
S003
S002 2019-04-05 Normal 180 Day Track No User Fee
S001

NIH GUDID Devices

Device IDPMASupp
00854111006006 P170032 000
00856956005572 P170032 000
00856956005817 P170032 000
00856956005824 P170032 000
00856956005831 P170032 000
00856956005848 P170032 000
00856956005855 P170032 000
00856956005862 P170032 000
00856956005879 P170032 000
00856956005886 P170032 000
00856956005893 P170032 000
00856956005909 P170032 000
00856956005916 P170032 000
00856956005923 P170032 000
00856956005930 P170032 000
00856956005947 P170032 000
00856956005954 P170032 000
00856956005961 P170032 000
00856956005565 P170032 000
00856956005558 P170032 000
00854111006013 P170032 000
00854111006020 P170032 000
00854111006037 P170032 000
00854111006044 P170032 000
00854111006051 P170032 000
00854111006068 P170032 000
00854111006075 P170032 000
00854111006082 P170032 000
00854111006099 P170032 000
00854111006105 P170032 000
00854111006112 P170032 000
00854111006129 P170032 000
00854111006136 P170032 000
00854111006143 P170032 000
00854111006150 P170032 000
10856956005289 P170032 000
00856956005541 P170032 000
00856956005978 P170032 000
00856956005985 P170032 000
00842429107348 P170032 000
00842429107171 P170032 000
00842429107188 P170032 000
00842429107324 P170032 000
00842429107195 P170032 000
00842429107201 P170032 000
00842429107218 P170032 000
00842429107225 P170032 000
00842429107232 P170032 000
00842429107249 P170032 000
00842429107256 P170032 000
00842429107263 P170032 000
00842429107270 P170032 000
00842429107287 P170032 000
00842429107294 P170032 000
00842429107300 P170032 000
00842429107317 P170032 000
00842429107331 P170032 000
00842429107164 P170032 000
00842429107157 P170032 000
00842429107027 P170032 000
00842429107010 P170032 000
00842429107003 P170032 000
00842429106990 P170032 000
00842429106983 P170032 000
00842429106976 P170032 000
00842429106969 P170032 000
00854111006167 P170032 000
00842429107034 P170032 000
00842429107041 P170032 000
00842429107140 P170032 000
00842429107133 P170032 000
00842429107119 P170032 000
00842429107102 P170032 000
00842429107096 P170032 000
00842429107089 P170032 000
00842429107072 P170032 000
00842429107058 P170032 000
10842429103125 P170032 003
00842429110850 P170032 004
00842429110843 P170032 004
00842429110836 P170032 004
00842429110829 P170032 004
00842429110812 P170032 004
00842429110805 P170032 004
00842429110799 P170032 004
00842429118009 P170032 004
00842429110867 P170032 004
00842429110874 P170032 004
00842429110881 P170032 004
00842429110966 P170032 004
00842429110959 P170032 004
00842429110942 P170032 004
00842429110935 P170032 004
00842429110928 P170032 004
00842429110911 P170032 004
00842429110904 P170032 004
00842429110898 P170032 004
00842429117996 P170032 004

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.