SUPRIMA II MODEL 254-26

Implantable Pacemaker Pulse-generator

INTERMEDICS, INC.

The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Suprima Ii Model 254-26.

Pre-market Notification Details

Device IDK852431
510k NumberK852431
Device Name:SUPRIMA II MODEL 254-26
ClassificationImplantable Pacemaker Pulse-generator
Applicant INTERMEDICS, INC. P.O. BOX 617 Freeport,  TX  77541 -0617
ContactLisa S Jones
CorrespondentLisa S Jones
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 Received1985-06-10
Decision Date1985-07-19

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