LOCATOR MODEL 4036

Permanent Pacemaker Electrode

PACESETTER, INC.

The following data is part of a premarket notification filed by Pacesetter, Inc. with the FDA for Locator Model 4036.

Pre-market Notification Details

Device IDK972814
510k NumberK972814
Device Name:LOCATOR MODEL 4036
ClassificationPermanent Pacemaker Electrode
Applicant PACESETTER, INC. 15900 VALLEY VIEW COURT P.O. BOX 9221 Sylmar,  CA  91342 -3577
ContactBetty M Johnson
CorrespondentBetty M Johnson
PACESETTER, INC. 15900 VALLEY VIEW COURT P.O. BOX 9221 Sylmar,  CA  91342 -3577
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSe Subject To Tracking Reg (ST)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-29
Decision Date1998-02-23
Summary:summary

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