MODEL 366-19 ADAPTAID ADAPTER SLEEVE

Permanent Pacemaker Electrode

INTERMEDICS, INC.

The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Model 366-19 Adaptaid Adapter Sleeve.

Pre-market Notification Details

Device IDK860985
510k NumberK860985
Device Name:MODEL 366-19 ADAPTAID ADAPTER SLEEVE
ClassificationPermanent Pacemaker Electrode
Applicant INTERMEDICS, INC. P.O. BOX 617 Freeport,  TX  77541 -0617
ContactKen Bishop
CorrespondentKen Bishop
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 Received1986-03-17
Decision Date1986-03-31

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