MODEL 480-01 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 480-01 Pacing Lead.

Pre-market Notification Details

Device IDK844270
510k NumberK844270
Device Name:MODEL 480-01 PACING 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 Received1984-11-05
Decision Date1985-03-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.