Neuroform Atlas® Stent System

FDA Premarket Approval P180031 S005

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

DeviceNeuroform Atlas® Stent System
Generic NameIntracranial Coil-assist Stent
ApplicantStryker Neurovascular47900 Bayside Parkwayfremont, CA 94538 PMA NumberP180031 Supplement NumberS005 Date Received09/20/2022 Decision Date11/15/2022 Product Code QCA  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-09-20
Decision Date2022-11-15
PMAP180031
SupplementS005
Product CodeQCA 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressStryker Neurovascular
47900 Bayside Parkway
fremont, CA 94538 PMA NumberP180031 Supplement NumberS005 Date Received09/20/2022 Decision Date11/15/2022 Product Code QCA  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For A Change To The In-process Specification Of The Inner Diameter Of The Nitinol Stent Component Of The Neuroform Atlas Stent System

Supplemental Filings

Supplement NumberDateSupplement Type
P180031Original Filing
S005 2022-09-20 30-day Notice
S004 2022-01-12 30-day Notice
S003 2020-08-04 30-day Notice
S002 2019-08-21 Normal 180 Day Track No User Fee
S001

NIH GUDID Devices

Device IDPMASupp
07613327382235 P180031 000
07613327382136 P180031 000
07613327382143 P180031 000
07613327382150 P180031 000
07613327382167 P180031 000
07613327382174 P180031 000
07613327382181 P180031 000
07613327382198 P180031 000
07613327382204 P180031 000
07613327382211 P180031 000
07613327382228 P180031 000
07613327382129 P180031 000

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