PMA P170024S018

Device: Surpass Elite Flow Diverter System
Applicant: Stryker Neurovascular
PMA number: P170024
Supplement: S018
Product code: OUT
Decision date: 2024-10-16
Classification: Neurology
Generic name: Intracranial aneurysm flow diverter
Approval order statement: approval for the following claim for the Surpass Elite Flow Diverter System for use in marketing materials: “Due to a proprietary surface modification, the implant has reduced thrombin generation when compared to unmodified stents based on acute in-vitro tests. Data derived from the referenced studies and may not be representative of clinical performance.”

Current openFDA PMA Record#

Device: Surpass Elite Flow Diverter System
Applicant: Stryker Neurovascular
PMA number: P170024
Supplement: S018
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2024-10-16
Decision code: APPR
Date received: 2024-07-19
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for the following claim for the Surpass Elite Flow Diverter System for use in marketing materials: “Due to a proprietary surface modification, the implant has reduced thrombin generation when compared to unmodified stents based on acute in-vitro tests. Data derived from the referenced studies and may not be representative of clinical performance.”