FDA.reportPublic FDA data

PMA P170024S003

Device
Surpass Evolve Flow Diverter System
Applicant
Stryker Neurovascular
PMA number
P170024
Supplement
S003
Product code
OUT
Decision date
2020-05-20
Generic name
Intracranial aneurysm flow diverter
Approval order statement
Approval for a change in the design of the approved Surpass Streamline Flow Diverter that consists of a new delivery system, smaller gauge wire in the stent to enable delivery through a smaller microcatheter, and reduce the number of cobalt chromium wires used in the stent braid.

Current openFDA PMA Record#

Device
Surpass Evolve Flow Diverter System
Applicant
Stryker Neurovascular
PMA number
P170024
Supplement
S003
Product code
OUT
Generic name
Intracranial aneurysm flow diverter
Decision date
2020-05-20
Decision code
APPR
Date received
2019-03-04
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change in the design of the approved Surpass Streamline Flow Diverter that consists of a new delivery system, smaller gauge wire in the stent to enable delivery through a smaller microcatheter, and reduce the number of cobalt chromium wires used in the stent braid.