PMA P180031S002
- Device
- Neuroform Atlas® Stent System
- Applicant
- Stryker Neurovascular
- PMA number
- P180031
- Supplement
- S002
- Product code
- QCA
- Decision date
- 2020-01-18
- Generic name
- Intracranial coil-assist stent
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Neuroform Atlas® Stent System
- Applicant
- Stryker Neurovascular
- PMA number
- P180031
- Supplement
- S002
- Product code
- QCA
- Generic name
- Intracranial coil-assist stent
- Decision date
- 2020-01-18
- Decision code
- APPR
- Date received
- 2019-08-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.