8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS

Implantable Pacemaker Pulse-generator

INTERMEDICS, INC.

The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for 8mm Quantum Pulse/suprima Ii Pulse Generators.

Pre-market Notification Details

Device IDK911122
510k NumberK911122
Device Name:8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
ClassificationImplantable Pacemaker Pulse-generator
Applicant INTERMEDICS, INC. P.O. BOX 617 Freeport,  TX  77541 -0617
ContactAlaine Medio
CorrespondentAlaine Medio
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 Received1991-03-12
Decision Date1991-05-16

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