ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER

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 Orion 40 Cardiac Stimulator & Pmp 200 Programmer.

Pre-market Notification Details

Device IDK852641
510k NumberK852641
Device Name:ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER
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 Received1985-06-20
Decision Date1986-01-14

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