ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM

Stylet, Catheter

ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI

The following data is part of a premarket notification filed by St. Jude Medical, Cardiac Rhythm Management Divisi with the FDA for St. Jude Medical, Cps Duo Left Heart Lead Delivery System.

Pre-market Notification Details

Device IDK072864
510k NumberK072864
Device Name:ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM
ClassificationStylet, Catheter
Applicant ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. Sylmar,  CA  91342
ContactColleen Canan
CorrespondentColleen Canan
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. Sylmar,  CA  91342
Product CodeDRB  
CFR Regulation Number870.1380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-05
Decision Date2008-03-13
Summary:summary

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