SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM

Implantable Pacemaker Pulse-generator

SORIN BIOMEDICA, FIAT, USA, INC.

The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Sorin Biomedica Orion 30/a Cardiac Stimulator & Pm.

Pre-market Notification Details

Device IDK851365
510k NumberK851365
Device Name:SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM
ClassificationImplantable Pacemaker Pulse-generator
Applicant SORIN BIOMEDICA, FIAT, USA, INC. JEANNE-MARIE VARGA 375 PARK AVENUE New York,  NY  10152
ContactJeanne-marie Varga
CorrespondentJeanne-marie Varga
SORIN BIOMEDICA, FIAT, USA, INC. JEANNE-MARIE VARGA 375 PARK AVENUE New York,  NY  10152
Product CodeDXY  
CFR Regulation Number870.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-05
Decision Date1985-12-03

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