MODEL 492-01 PACEMAKER LEAD

Permanent Pacemaker Electrode

INTERMEDICS, INC.

The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Model 492-01 Pacemaker Lead.

Pre-market Notification Details

Device IDK813136
510k NumberK813136
Device Name:MODEL 492-01 PACEMAKER LEAD
ClassificationPermanent Pacemaker Electrode
Applicant INTERMEDICS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-05
Decision Date1985-04-03

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