FASTPASS IMPLANTABLE ENDOCARD. PACING

Permanent Pacemaker Electrode

PACESETTER SYSTEMS

The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Fastpass Implantable Endocard. Pacing.

Pre-market Notification Details

Device IDK821947
510k NumberK821947
Device Name:FASTPASS IMPLANTABLE ENDOCARD. PACING
ClassificationPermanent Pacemaker Electrode
Applicant PACESETTER SYSTEMS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-06-30
Decision Date1982-08-06

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