Cleared Traditional

OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004

K882474 · Ela Medical, Inc. · Cardiovascular
Sep 1988
Decision
89d
Days
Class 3
Risk

About This 510(k) Submission

K882474 is an FDA 510(k) clearance for the OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004, a Implantable Pacemaker Pulse-generator (Class III — Premarket Approval, product code DXY), submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on September 12, 1988, 89 days after receiving the submission on June 15, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number K882474 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 1988
Decision Date September 12, 1988
Days to Decision 89 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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