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Formula Balloon-Expandable Renal Stent System

by Cook Medical Incorporated

PMA P100028

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P100028↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP100028 Date14 Jan 2011ApprovedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1940-2020 FDA Class II initiated 15 Apr 2020

    The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedural time and additional intervention to remove a stent that dislodged within an unintended location.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Formula Ballool-Expandable Renal Stent System
Trade Name
Formula Balloon-Expandable Renal Stent System
Generic Name
STENT, RENAL
PMA Number
FDA Product Code
NIN
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Formula Balloon-Expandable Renal Stent System is a Class III balloon-expandable renal stent designed for use in patients with atherosclerotic disease of the renal arteries. It is intended for deployment following suboptimal percutaneous transluminal renal angioplasty (PTRA) of de novo or restenotic lesions up to 18 mm in length, located within 10 mm of the renal ostium with a reference vessel diameter between 4.0 mm and 7.0 mm.

This system is supplied as a sterile, single-use device and is regulated under an FDA Premarket Approval (PMA) application (P100028). It is intended for use in controlled clinical settings, such as interventional radiology or cardiology suites, where imaging guidance is available. The device is not MRI-safe and must be handled and stored according to manufacturer instructions to maintain sterility and functionality.

Other devices from Cook Medical Incorporated

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What specific clinical scenarios is the Formula Balloon-Expandable Renal Stent System designed to address in patients with renal artery disease?

    This stent system is specifically intended for patients with atherosclerotic disease of the renal arteries who have undergone suboptimal percutaneous transluminal renal angioplasty (PTRA). It is used to treat de novo or restenotic lesions up to 18 mm long, located within 10 mm of the renal ostium, with a reference vessel diameter between 4.0 mm and 7.0 mm. Suboptimal PTRA is defined by residual stenosis of ≥50%, a systolic pressure gradient of ≥20 mmHg, a mean translesional pressure gradient of ≥10 mmHg, or flow-limiting dissection.

  • Is the Formula Balloon-Expandable Renal Stent System intended for repeated use, or is it meant to be used once and then discarded?

    The device is supplied as a sterile, single-use system. It is not designed for reuse, and proper handling and storage instructions must be followed to maintain sterility and functionality for one-time clinical use.

  • What type of imaging guidance is required when using the Formula Balloon-Expandable Renal Stent System?

    The device is intended for use in controlled clinical settings, such as interventional radiology or cardiology suites, where imaging guidance is available. This ensures precise deployment and assessment of the renal artery during the procedure.

  • Can the Formula Balloon-Expandable Renal Stent System be used in patients with renal artery lesions that extend beyond 10 mm from the renal ostium?

    No, the device is specifically indicated for lesions located *within* 10 mm of the renal ostium. Lesions extending beyond this distance are not covered by the intended use of this stent system.

  • What storage and handling precautions must be taken to ensure the device remains functional and sterile?

    The device must be handled and stored according to the manufacturer’s instructions to preserve sterility and functionality. Since it is single-use, it should remain unopened until immediately before use and stored in a way that prevents contamination or damage.