Neuroform Atlas® Stent System

FDA Premarket Approval P180031 S002

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

The neuroform atlas stent system is indicated for use with neurovascular embolization coils in the anterior circulation of the neurovasculature for the endovascular treatment of patients? 18 years of age with saccular wide-necked (neck width? 4 mm or a dome-to-neck ratio of < 2) intracranial aneurysms arising from a parent vessel with a diameter of? 2. 0 mm and? 4. 5 mm.

DeviceNeuroform Atlas® Stent System
Generic NameIntracranial Coil-assist Stent
ApplicantStryker Neurovascular
Date Received2019-08-21
Decision Date2020-01-18
PMAP180031
SupplementS002
Product CodeQCA 
Advisory CommitteeNeurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address Stryker Neurovascular 47900 Bayside Parkway fremont, CA 94538

Supplemental Filings

Supplement NumberDateSupplement Type
P180031Original Filing
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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