PMA P180031S011
- Device
- Neuroform Atlas Stent System
- Applicant
- Stryker Neurovascular
- PMA number
- P180031
- Supplement
- S011
- Product code
- QCA
- Decision date
- 2025-05-09
- Classification
- Neurology
- Generic name
- Intracranial coil-assist stent
- Approval order statement
- to introduce a new degreaser solvent to use in the manufacture of the Radiopaque Marker Band
Current openFDA PMA Record#
- Device
- Neuroform Atlas Stent System
- Applicant
- Stryker Neurovascular
- PMA number
- P180031
- Supplement
- S011
- Product code
- QCA
- Generic name
- Intracranial coil-assist stent
- Decision date
- 2025-05-09
- Decision code
- OK30
- Date received
- 2025-04-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to introduce a new degreaser solvent to use in the manufacture of the Radiopaque Marker Band