Cleared Traditional

IMPLANTABLE PULSE GENERATOR (K834096) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K834096 · Intermedics, Inc. · Cardiovascular device
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Dec 1983
Decision
18d
Days
Class 3
Risk

K834096 is an FDA 510(k) clearance for the IMPLANTABLE PULSE GENERATOR. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1983 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Intermedics, Inc. devices

Submission Details

510(k) Number K834096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1983
Decision Date December 16, 1983
Days to Decision 18 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DXY Implantable Pacemaker Pulse-generator

All 181
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K834096.
PACEMAKER 147 VVI-THE OPTINIA
K840701 · Telectronics, Inc. · May 1984
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN
K833427 · Telectronics, Inc. · Feb 1984
IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN
K833428 · Telectronics, Inc. · Feb 1984
OPTIMA MDT PULSE GENERATOR W/TELEMETRY
K833798 · Telectronics, Inc. · Dec 1983
PRIMA-UNIPOLAR CARDIAC PULSE GENERAT
K832914 · Intermedics, Inc. · Nov 1983
SILICONE RUBBER ISOLATION SLEEVE 350-01
K833199 · Intermedics, Inc. · Oct 1983