Poly Flex Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K802295 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Intermedics, Inc. →

• What is the Poly Flex Implantable Pacing Lead used for in clinical practice?

  The Poly Flex Implantable Pacing Lead is designed to deliver electrical stimulation to the heart for patients with bradycardia or conduction disorders. It regulates cardiac rhythm by providing consistent pacing impulses, ensuring proper heart function in individuals who require chronic cardiac support.

• Is the Poly Flex Implantable Pacing Lead intended for single-use or can it be reused?

  The Poly Flex Implantable Pacing Lead is explicitly supplied sterile and intended for single-use implantation within the cardiovascular system. Reuse is not recommended or supported by the manufacturer.

• How is the Poly Flex Implantable Pacing Lead regulated in the U.S.?

  This device is classified as a Class III medical device under FDA regulations and has received 510(k) clearance (K802295). It adheres to strict manufacturing and performance standards for implantable cardiac devices, including compliance with product code DTB and multiple registration numbers (e.g., 2017865).

• What type of sterility assurance does the Poly Flex Implantable Pacing Lead provide?

  The Poly Flex Implantable Pacing Lead is supplied sterile by the manufacturer, ensuring it meets safety standards for direct implantation into the cardiovascular system without additional sterilization by the clinician.

• What advisory committee reviewed this device during its regulatory submission?

  The Poly Flex Implantable Pacing Lead was reviewed by the Cardiovascular (CV) Advisory Committee as part of its 510(k) submission, reflecting its classification under cardiovascular medical devices.