S80 IMPLANTABLE CARDIAC PACING LEAD

Permanent Pacemaker Electrode

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 S80 Implantable Cardiac Pacing Lead.

Pre-market Notification Details

Device IDK854963
510k NumberK854963
Device Name:S80 IMPLANTABLE CARDIAC PACING LEAD
ClassificationPermanent Pacemaker Electrode
Applicant SORIN BIOMEDICA, FIAT, USA, INC. VIA CRESCENTINO 13040 SALUGGIA (VC) Italy,  IT
ContactMaria Varga
CorrespondentMaria Varga
SORIN BIOMEDICA, FIAT, USA, INC. VIA CRESCENTINO 13040 SALUGGIA (VC) Italy,  IT
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-11
Decision Date1986-06-24

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