Cleared Traditional

OPTIMA MPT AND SPT PACEMAKERS

K884411 · Telectronics, Inc. · Cardiovascular
Jan 1989
Decision
98d
Days
Class 3
Risk

About This 510(k) Submission

K884411 is an FDA 510(k) clearance for the OPTIMA MPT AND SPT PACEMAKERS, a Implantable Pacemaker Pulse-generator (Class III — Premarket Approval, product code DXY), submitted by Telectronics, Inc. (Englewood, US). The FDA issued a Cleared decision on January 26, 1989, 98 days after receiving the submission on October 20, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number K884411 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1988
Decision Date January 26, 1989
Days to Decision 98 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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