BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)

Permanent Pacemaker Electrode

INTERMEDICS, INC.

The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Biplr Im En Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07).

Pre-market Notification Details

Device IDK962174
510k NumberK962174
Device Name:BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
ClassificationPermanent Pacemaker Electrode
Applicant INTERMEDICS, INC. 4000 TECHNOLOGY DR. Angleton,  TX  77515
ContactLori Kleinschrodt Holder
CorrespondentLori Kleinschrodt Holder
INTERMEDICS, INC. 4000 TECHNOLOGY DR. Angleton,  TX  77515
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSe Subject To Tracking Reg (ST)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-05
Decision Date1996-08-21
Summary:summary

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