8mm Quantum Pulse/Suprima II Pulse Generators

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K911122 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

  Class III

  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• Are these pulse generators designed for reuse or single-use after implantation, and what does that mean for clinical workflows?

  The 8MM Quantum Pulse/Suprema II Pulse Generators are supplied sterile for single-use only, meaning each device is intended for one surgical implantation and should not be reused. This ensures patient safety by preventing cross-contamination and maintaining device integrity, which is critical for life-sustaining cardiac rhythm regulation. Clinically, this means each unit must be opened and prepared for a single procedure, requiring proper inventory management to avoid shortages.

• What storage requirements should be followed for these pulse generators before implantation?

  Since these devices are sterile and single-use, they must be stored in their original packaging until ready for use. The packaging should remain unopened and protected from contamination, moisture, or physical damage. Proper storage conditions—typically at room temperature away from direct sunlight—are essential to preserve sterility and functionality until implantation. Always check expiration dates and follow manufacturer guidelines for handling.

• What are the key differences between the 8MM Quantum Pulse/Suprema II and other pacemaker pulse generators in terms of regulatory approval?

  The 8MM Quantum Pulse/Suprema II was granted FDA 510(k) clearance (K911122) under the product code DXY, classified as substantially equivalent to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously approved pacemaker pulse generator, ensuring it meets safety and effectiveness standards for regulating cardiac rhythm. The decision was reviewed by the Cardiovascular (CV) Advisory Committee, reinforcing its classification as a Class III device due to its role in life-sustaining functions.

• Are there multiple sizes or models available within the 8MM Quantum Pulse/Suprema II line, or is this a fixed specification?

  The name explicitly indicates these are 8MM Quantum Pulse/Suprema II pulse generators, suggesting a standardized size (8mm) for this specific model line. While the data does not list additional sizes or models, the OpenFDA registration numbers imply multiple lot-specific units were produced under this designation. Always verify the exact model and specifications with the manufacturer or packaging to confirm compatibility with your patient’s needs, as variations in battery life or programming may exist across lots.