FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Intrasaccular Flow Disruption Device
PMA: P170032
·
Supplement: S010
·
Decision Dec 20, 2021
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Intrasaccular Flow Disruption Device
- Trade Name
- (WEB) Aneurysm Embolization System
- PMA Number
- P170032
- Supplement Number
- S010
- Device Class
- FDA Class 3
- Product Code
- OPR
- Generic Name
- Intrasaccular Flow Disruption Device
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 20, 2021
- Date Received
- November 22, 2021
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Change in bacterial endotoxin test sampling plan and to update the manufacturing procedure to conduct bacterial endotoxin testing prior to device sterilization.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OPR | Intrasaccular Flow Disruption Device | FDA class 3 | Unknown |