PMA P180031S008
- Device
- Neuroform Atlas® Stent System
- Applicant
- Stryker Neurovascular
- PMA number
- P180031
- Supplement
- S008
- Product code
- QCA
- Decision date
- 2024-09-20
- Classification
- Neurology
- Generic name
- Intracranial coil-assist stent
- Approval order statement
- approval for addition of a 100% in-process inspection to verify that welds of the stent delivery wire meet specifications
Current openFDA PMA Record#
- Device
- Neuroform Atlas® Stent System
- Applicant
- Stryker Neurovascular
- PMA number
- P180031
- Supplement
- S008
- Product code
- QCA
- Generic name
- Intracranial coil-assist stent
- Decision date
- 2024-09-20
- Decision code
- OK30
- Date received
- 2024-09-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for addition of a 100% in-process inspection to verify that welds of the stent delivery wire meet specifications