PMA P170032S016
- Device
- Woven EndoBridge (WEB) Aneurysm Embolization System
- Applicant
- MicroVention, Inc.
- PMA number
- P170032
- Supplement
- S016
- Product code
- OPR
- Decision date
- 2024-08-14
- Classification
- Neurology
- Generic name
- Intrasaccular Flow Disruption Device
- Approval order statement
- approval of the revised protocol for the post-approval study (PAS) titled “PAS1 - PostMarket Surveillance-Long Term Safety”.
Current openFDA PMA Record#
- Device
- Woven EndoBridge (WEB) Aneurysm Embolization System
- Applicant
- MicroVention, Inc.
- PMA number
- P170032
- Supplement
- S016
- Product code
- OPR
- Generic name
- Intrasaccular Flow Disruption Device
- Decision date
- 2024-08-14
- Decision code
- APPR
- Date received
- 2024-05-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- approval of the revised protocol for the post-approval study (PAS) titled “PAS1 - PostMarket Surveillance-Long Term Safety”.