|
Device | Surpass Streamline Flow Diverter |
Generic Name | Intracranial aneurysm flow diverter |
Applicant | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 |
PMA Number | P170024 |
Supplement Number | S004 |
Date Received | 06/02/2020 |
Decision Date | 09/14/2020 |
Product Code |
OUT |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a shelf-life extension of the Surpass Streamline Flow Diverter from one year to three years. |