PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING

Permanent Pacemaker Electrode

PACESETTER, INC.

The following data is part of a premarket notification filed by Pacesetter, Inc. with the FDA for Passive Plus Pacing Leads With Titanium Nitride Coating.

Pre-market Notification Details

Device IDK952206
510k NumberK952206
Device Name:PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING
ClassificationPermanent Pacemaker Electrode
Applicant PACESETTER, INC. 15900 VAKLLEY VIEW COURT Sylmar,  CA  91342 -3577
ContactPaul Mason
CorrespondentPaul Mason
PACESETTER, INC. 15900 VAKLLEY VIEW COURT Sylmar,  CA  91342 -3577
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSe - Postmarket Surveillance Required (SESP)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-10
Decision Date1995-08-31

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