Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Neuroform Atlas® Stent System
• Generic Name: Intracranial coil-assist stent
• Applicant: Stryker Neurovascular; 47900 Bayside Pkwy.; Fremont, CA 94538
• PMA Number: P180031
• Supplement Number: S001
• Date Received: 07/22/2019
• Decision Date: 07/30/2020
• Product Code: QCA
• Docket Number: 20M-1726
• Notice Date: 08/03/2020
• Advisory Committee: Neurology
• Clinical Trials: NCT02340585
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the Neuroform Atlas Stent System indicated for use with neurovascular embolization coils in the anterior and posterior circulation of the neurovasculature for the endovascular treatment of patients >= 18 years of age with saccular wide-necked (neck width >= 4 mm or a dome-to-neck ratio of < 2) intracranial aneurysms arising from a parent vessel with a diameter of >= 2.0 mm and <= 4.5 mm.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling