FDA.reportPublic FDA data

PMA P170032S015

Device
Woven EndoBridge (WEB) Aneurysm Embolization System
Applicant
MicroVention, Inc.
PMA number
P170032
Supplement
S015
Product code
OPR
Decision date
2023-10-04
Classification
Neurology
Generic name
Intrasaccular Flow Disruption Device
Approval order statement
Use of a new measurement equipment to automate the dimensional inspection of the Woven EndoBridge (WEB) implant of the WEB Aneurysm Embolization System.

Current openFDA PMA Record#

Device
Woven EndoBridge (WEB) Aneurysm Embolization System
Applicant
MicroVention, Inc.
PMA number
P170032
Supplement
S015
Product code
OPR
Generic name
Intrasaccular Flow Disruption Device
Decision date
2023-10-04
Decision code
OK30
Date received
2023-09-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of a new measurement equipment to automate the dimensional inspection of the Woven EndoBridge (WEB) implant of the WEB Aneurysm Embolization System.