MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS

Implantable Pacemaker Pulse-generator

INTERMEDICS, INC.

The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Modified Models 253-19 & 254-20 Quantum Generators.

Pre-market Notification Details

Device IDK873528
510k NumberK873528
Device Name:MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS
ClassificationImplantable Pacemaker Pulse-generator
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 CodeDXY  
CFR Regulation Number870.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-01
Decision Date1987-10-09

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