PMA P180031S003
- Device
- Neuroform Atlas Stent System
- Applicant
- Stryker Neurovascular
- PMA number
- P180031
- Supplement
- S003
- Product code
- QCA
- Decision date
- 2020-08-18
- Generic name
- Intracranial coil-assist stent
- Approval order statement
- Process change for the removal of a cleaning step for the Neuroform Atlas Stent System.
Current openFDA PMA Record#
- Device
- Neuroform Atlas Stent System
- Applicant
- Stryker Neurovascular
- PMA number
- P180031
- Supplement
- S003
- Product code
- QCA
- Generic name
- Intracranial coil-assist stent
- Decision date
- 2020-08-18
- Decision code
- OK30
- Date received
- 2020-08-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process change for the removal of a cleaning step for the Neuroform Atlas Stent System.