Surpass Evolve Flow Diverter System, Surpass Streamline Flow Diverter System

FDA Premarket Approval P170024 S007

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.

Pre-market Approval Supplement Details

Changes to the braid component incoming inspection to remove redundant inspections and accept a certificate of conformance/certificate of analysis from the supplier

DeviceSurpass Evolve Flow Diverter System, Surpass Streamline Flow Diverter System
Generic NameIntracranial Aneurysm Flow Diverter
ApplicantStryker Neurovascular
Date Received2021-04-14
Decision Date2021-04-27
PMAP170024
SupplementS007
Product CodeOUT 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Stryker Neurovascular 47900 Bayside Parkway fremont, CA 94538

Supplemental Filings

Supplement NumberDateSupplement Type
P170024Original Filing
S007 2021-04-14 30-day Notice
S006 2020-11-24 30-day Notice
S005 2020-10-26 30-day Notice
S004 2020-06-02 Real-time Process
S003 2019-03-04 Normal 180 Day Track
S002 2018-10-15 Special (immediate Track)
S001 2018-09-20 30-day Notice

NIH GUDID Devices

Device IDPMASupp
07613252648864 P170024 001
07613252648734 P170024 001
07613252648741 P170024 001
07613252648758 P170024 001
07613252648765 P170024 001
07613252648772 P170024 001
07613252648789 P170024 001
07613252648796 P170024 001
07613252648802 P170024 001
07613252648819 P170024 001
07613252648826 P170024 001
07613252648833 P170024 001
07613252648840 P170024 001
07613252648857 P170024 001
07613327385632 P170024 003
07613327385625 P170024 003
07613327375329 P170024 003
07613327375312 P170024 003
07613327375305 P170024 003
07613327385649 P170024 003
07613327385656 P170024 003
07613327385663 P170024 003
07613327385670 P170024 003
07613327386486 P170024 003
07613327386493 P170024 003
07613327386509 P170024 003
07613327375299 P170024 003
07613327375282 P170024 003
07613327375275 P170024 003
07613327375169 P170024 003
07613327375176 P170024 003
07613327375183 P170024 003
07613327375190 P170024 003
07613327375206 P170024 003
07613327375213 P170024 003
07613327375220 P170024 003
07613327375237 P170024 003
07613327375244 P170024 003
07613327375251 P170024 003
07613327375268 P170024 003
07613327375152 P170024 003
07613327386516 P170024 003
07613327386523 P170024 003
07613327386677 P170024 003
07613327386684 P170024 003
07613327386691 P170024 003
07613327386707 P170024 003
07613327386714 P170024 003
07613327386721 P170024 003
07613327386738 P170024 003
07613327386745 P170024 003
07613327386752 P170024 003
07613327386769 P170024 003
07613327386776 P170024 003
07613327386660 P170024 003
07613327386653 P170024 003
07613327386646 P170024 003
07613327386530 P170024 003
07613327386547 P170024 003
07613327386554 P170024 003
07613327386561 P170024 003
07613327386578 P170024 003
07613327386585 P170024 003
07613327386592 P170024 003
07613327386608 P170024 003
07613327386615 P170024 003
07613327386622 P170024 003
07613327386639 P170024 003
07613327386783 P170024 003

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.