FDA.reportPublic FDA data

PMA P170024S007

Device
Surpass Evolve Flow Diverter System, Surpass Streamline Flow Diverter System
Applicant
Stryker Neurovascular
PMA number
P170024
Supplement
S007
Product code
OUT
Decision date
2021-04-27
Generic name
Intracranial aneurysm flow diverter
Approval order statement
Changes to the braid component incoming inspection to remove redundant inspections and accept a Certificate of Conformance/Certificate of Analysis from the supplier.

Current openFDA PMA Record#

Device
Surpass Evolve Flow Diverter System, Surpass Streamline Flow Diverter System
Applicant
Stryker Neurovascular
PMA number
P170024
Supplement
S007
Product code
OUT
Generic name
Intracranial aneurysm flow diverter
Decision date
2021-04-27
Decision code
OK30
Date received
2021-04-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to the braid component incoming inspection to remove redundant inspections and accept a Certificate of Conformance/Certificate of Analysis from the supplier.