MODEL 492-02 ENDOCARDIAL PACING LEAD

Permanent Pacemaker Electrode

INTERMEDICS, INC.

The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Model 492-02 Endocardial Pacing Lead.

Pre-market Notification Details

Device IDK860548
510k NumberK860548
Device Name:MODEL 492-02 ENDOCARDIAL PACING LEAD
ClassificationPermanent Pacemaker Electrode
Applicant INTERMEDICS, INC. P.O. BOX 617 Freeport,  TX  77541 -0617
ContactDavid M Makanani
CorrespondentDavid M Makanani
INTERMEDICS, INC. P.O. BOX 617 Freeport,  TX  77541 -0617
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-13
Decision Date1986-06-13

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