Poly-Flex Pacing Leads

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K813028 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

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 the Poly-Flex Pacing Leads designed for reuse or are they intended for single-use only?

  The Poly-Flex Pacing Leads are explicitly designed for single-use implantation only. This is clearly stated in the device description, ensuring they are used once and then discarded to maintain sterility and patient safety.

• What types of heart conditions are these leads intended to address, and how do they work?

  These leads are intended for patients with bradycardia or conduction disorders, delivering regulated electrical impulses to the heart to maintain proper rhythm. They are implanted within the heart as part of a cardiac pacing system, ensuring consistent pacing when the heart’s natural conduction system is impaired.

• How are the Poly-Flex Pacing Leads supplied, and are they sterile upon receipt?

  The leads are supplied sterile and ready for immediate use, as specified in the device description. This ensures they meet regulatory standards for cardiovascular procedures without requiring additional sterilization before implantation.

• What regulatory pathway was followed for FDA clearance of these leads, and which advisory committee reviewed them?

  The Poly-Flex Pacing Leads received FDA 510(k) clearance (K813028) under the Traditional pathway, with a decision of *Substantially Equivalent* (SESE). The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting their classification as a Class 3 medical device under regulation 870.3680.

• How many model references are associated with the Poly-Flex Pacing Leads, and what does this indicate about their availability?

  The device includes multiple model references (listed in the FDA database, e.g., 3002618605, 1028232, etc.), suggesting a range of configurations or sizes to accommodate different patient anatomies or clinical needs. This variety ensures compatibility with various cardiac pacing systems and implantation scenarios.