PMA P180031S005
- Device
- Neuroform Atlas® Stent System
- Applicant
- Stryker Neurovascular
- PMA number
- P180031
- Supplement
- S005
- Product code
- QCA
- Decision date
- 2022-11-15
- Generic name
- Intracranial coil-assist stent
- Approval order statement
- Change to the in-process specification of the inner diameter of the nitinol stent component of the Neuroform Atlas Stent System,
Current openFDA PMA Record#
- Device
- Neuroform Atlas® Stent System
- Applicant
- Stryker Neurovascular
- PMA number
- P180031
- Supplement
- S005
- Product code
- QCA
- Generic name
- Intracranial coil-assist stent
- Decision date
- 2022-11-15
- Decision code
- OK30
- Date received
- 2022-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the in-process specification of the inner diameter of the nitinol stent component of the Neuroform Atlas Stent System,