PMA P170032S004

Device
Woven EndoBridge (WEB) Aneurysm Embolization System (WEB 017)
Applicant
MicroVention, Inc.
Product code
OPR
Decision date
2021-01-11
Generic name
Intrasaccular Flow Disruption Device
Approval order statement
Approval for new device models of the WEB Aneurysm Embolization System (WEB 017).

Current openFDA PMA Record#

Device
Woven EndoBridge (WEB) Aneurysm Embolization System (WEB 017)
Applicant
MicroVention, Inc.
PMA number
P170032
Supplement
S004
Product code
OPR
Generic name
Intrasaccular Flow Disruption Device
Decision date
2021-01-11
Decision code
APPR
Date received
2019-07-19
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for new device models of the WEB Aneurysm Embolization System (WEB 017).