MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855

Shunt, Central Nervous System And Components

MEDTRONIC PS MEDICAL

The following data is part of a premarket notification filed by Medtronic Ps Medical with the FDA for Medtronic Ps Medical Strata Valve, Models 42855, 42865, 92865, 92855.

Pre-market Notification Details

Device IDK012052
510k NumberK012052
Device Name:MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855
ClassificationShunt, Central Nervous System And Components
Applicant MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta,  CA  93117 -5500
ContactJeff Henderson
CorrespondentJeff Henderson
MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta,  CA  93117 -5500
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-02
Decision Date2002-02-11
Summary:summary

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