Cleared Traditional

INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD

K902672 · Intermedics, Inc. · Cardiovascular
Mar 1991
Decision
256d
Days
Class 3
Risk

About This 510(k) Submission

K902672 is an FDA 510(k) clearance for the INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on March 1, 1991, 256 days after receiving the submission on June 18, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K902672 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1990
Decision Date March 01, 1991
Days to Decision 256 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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