Cleared Traditional

PRIMA-UNIPOLAR CARDIAC PULSE GENERAT (K832914) - FDA 510(k) Clearance

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

K832914 · Intermedics, Inc. · Cardiovascular device
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Nov 1983
Decision
77d
Days
Class 3
Risk

K832914 is an FDA 510(k) clearance for the PRIMA-UNIPOLAR CARDIAC PULSE GENERAT. 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 November 14, 1983 after a review of 77 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 K832914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1983
Decision Date November 14, 1983
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 K832914.
IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN
K833428 · Telectronics, Inc. · Feb 1984
IMPLANTABLE PULSE GENERATOR
K834096 · Intermedics, Inc. · Dec 1983
OPTIMA MDT PULSE GENERATOR W/TELEMETRY
K833798 · Telectronics, Inc. · Dec 1983
SILICONE RUBBER ISOLATION SLEEVE 350-01
K833199 · Intermedics, Inc. · Oct 1983
SILICONE RUBBER ISOLATION SLEEVE 351-01
K833198 · Intermedics, Inc. · Oct 1983
QUANTUM BIPOLAR CARDIAC PULSE GENERATOR
K831633 · Intermedics, Inc. · Oct 1983