Cleared Traditional

INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD

K903948 · Intermedics, Inc. · Cardiovascular
Apr 1991
Decision
238d
Days
Class 3
Risk

About This 510(k) Submission

K903948 is an FDA 510(k) clearance for the INTERMEDICS MODEL 431-11 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 April 22, 1991, 238 days after receiving the submission on August 27, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K903948 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1990
Decision Date April 22, 1991
Days to Decision 238 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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