Cleared Traditional

K861140 - PROGRAMALITH III PULSE GENERATOR

K861140 is an FDA 510(k) clearance for PROGRAMALITH III PULSE GENERATOR, manufactured by Pacesetter Systems. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K861140 · Pacesetter Systems · Cardiovascular device
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May 1986
Decision
37d
Days
Class 3
Risk

K861140 is an FDA 510(k) clearance for the PROGRAMALITH III PULSE GENERATOR. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 37 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 Pacesetter Systems devices

FDA 510(k) Submission Details - K861140

510(k) Number K861140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1986
Decision Date May 02, 1986
Days to Decision 37 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
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

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 393
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K861140.
MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN
K862071 · Medtronic Vascular · Jun 1986
IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR
K860573 · Telectronics, Inc. · May 1986
SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS
K861559 · Cook Pacemaker Corp. · May 1986
BIPOLAR CARDIAC PACEMAKER, MODEL 110
K861009 · Cardiac Control Systems, Inc. · Apr 1986
UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762
K852973 · Ela Medical, Inc. · Mar 1986
MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS
K855147 · Medtronic Vascular · Mar 1986