Cleared Traditional

INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

K954719 · Intermedics, Inc. · Cardiovascular
Feb 1996
Decision
137d
Days
Class 3
Risk

About This 510(k) Submission

K954719 is an FDA 510(k) clearance for the INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Intermedics, Inc. (Angleton, US). The FDA issued a Cleared decision on February 27, 1996, 137 days after receiving the submission on October 13, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K954719 FDA.gov
FDA Decision Cleared ST
Date Received October 13, 1995
Decision Date February 27, 1996
Days to Decision 137 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DTB — Permanent Pacemaker Electrode
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3680

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