PSA Cable

Analyzer, Pacemaker Generator Function

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Psa Cable.

Pre-market Notification Details

Device IDK170815
510k NumberK170815
Device Name:PSA Cable
ClassificationAnalyzer, Pacemaker Generator Function
Applicant Boston Scientific Corporation 4100 Hamline Ave North St. Paul,  MN  55112
ContactMelissa Klamerus
CorrespondentMelissa Klamerus
Boston Scientific Corporation 4100 Hamline Ave North St. Paul,  MN  55112
Product CodeDTC  
CFR Regulation Number870.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-17
Decision Date2017-07-06
Summary:summary

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