Cleared Traditional

OPUS S MODEL 4121 AND 4124 PACEMAKERS

K970072 · Ela Medical, Inc. · Cardiovascular
Aug 1997
Decision
233d
Days
Class 3
Risk

About This 510(k) Submission

K970072 is an FDA 510(k) clearance for the OPUS S MODEL 4121 AND 4124 PACEMAKERS, a Implantable Pacemaker Pulse-generator (Class III — Premarket Approval, product code DXY), submitted by Ela Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 29, 1997, 233 days after receiving the submission on January 8, 1997. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number K970072 FDA.gov
FDA Decision Cleared ST
Date Received January 08, 1997
Decision Date August 29, 1997
Days to Decision 233 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DXY — Implantable Pacemaker Pulse-generator
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3610

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