Surpass Streamline Flow Diverter

Intracranial Aneurysm Flow Diverter

FDA Premarket Approval P170024 S001

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

Reduction of the frequency of in-process inspection for the pouch sealing process to once daily.

DeviceSurpass Streamline Flow Diverter
Classification NameIntracranial Aneurysm Flow Diverter
Generic NameIntracranial Aneurysm Flow Diverter
ApplicantStryker Neurovascular
Date Received2018-09-20
Decision Date2018-10-05
PMAP170024
SupplementS001
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
S011 2021-11-09 30-day Notice
S010
S009 2021-06-30 30-day Notice
S008 2021-06-07 30-day Notice
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
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