Cleared Traditional

MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD

K922972 · Intermedics, Inc. · Cardiovascular
Jan 1993
Decision
217d
Days
Class 3
Risk

About This 510(k) Submission

K922972 is an FDA 510(k) clearance for the MODELS 438-05 AND 435-05 IMPLANTABLE 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 January 22, 1993, 217 days after receiving the submission on June 19, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K922972 FDA.gov
FDA Decision Cleared SESP
Date Received June 19, 1992
Decision Date January 22, 1993
Days to Decision 217 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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

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