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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K152700
Device Name StrataMR Valves and Shunts
Applicant
Medtronic Neurosurgery
125 Cremona Dr.
Goleta,  CA  93117
Applicant Contact Micah Schloss
Correspondent
Medtronic Neurosurgery
125 Cremona Dr.
Goleta,  CA  93117
Correspondent Contact Deep Pal
Regulation Number882.5550
Classification Product Code
JXG  
Date Received09/21/2015
Decision Date 04/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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