PACEART OPTIMA SYSTEM SOFTWARE

Analyzer, Pacemaker Generator Function, Indirect

MEDTRONIC, INC.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Paceart Optima System Software.

Pre-market Notification Details

Device IDK110693
510k NumberK110693
Device Name:PACEART OPTIMA SYSTEM SOFTWARE
ClassificationAnalyzer, Pacemaker Generator Function, Indirect
Applicant MEDTRONIC, INC. 8200 CORAL SEA STREET Mounds View,  MN  55304
ContactRachel U Libi
CorrespondentRachel U Libi
MEDTRONIC, INC. 8200 CORAL SEA STREET Mounds View,  MN  55304
Product CodeKRE  
Subsequent Product CodeDPS
Subsequent Product CodeDXH
Subsequent Product CodeOUG
CFR Regulation Number870.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-11
Decision Date2011-06-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169956810 K110693 000
00643169956803 K110693 000
00643169876927 K110693 000
00643169707351 K110693 000
00643169552296 K110693 000
00643169463523 K110693 000
00643169411296 K110693 000
00643169345058 K110693 000
00763000083342 K110693 000

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