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Palmaz Balloon Expandable Stent

by Cordis US Corporation PMAGUDID

Active United States

PMA P890017

Overview

The Palmaz Balloon Expandable Stent is a stent, renal, classified as a Class III medical device under the FDA’s nomenclature. It is designed to mechanically expand and maintain the patency of renal arteries by providing structural support to the vessel wall, preventing restenosis or occlusion following angioplasty procedures.

This device is delivered via a catheter-based approach and is deployed using a balloon-expansion technique, ensuring precise placement within the renal artery. Supplied as a single-use, sterile product, it requires specialized interventional radiology or cardiology settings for implantation. The Palmaz Balloon Expandable Stent holds an FDA Premarket Approval (PMA) under PMA number P890017, with regulatory compliance tied to its designated product code NIN for renal artery interventions.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10705032064736 UDI-DIDate7 May 2015ListedStatusIn distribution
United StatesFDA PMAAPPR PMA Approved NumberP890017 Date27 Sep 1991ApprovedStatusActive

Coverage

1 jurisdiction

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

United States — FDA PMA Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA · GUDID

Generic Name
STENT, RENAL PMA
Peripheral artery stent, bare-metal GUDID
Model / Ref / Catalog
P294
Primary DI / UDI-DI
10705032064736
PMA Number
FDA Product Code
NIN PMA
MAF GUDID
GMDN Term
Peripheral artery stent, bare-metal
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldPMAGUDID
Generic NamePMA
STENT, RENAL
GUDID
Peripheral artery stent, bare-metal
FDA Product CodePMA
NIN
GUDID
MAF

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Questions

  • What is the primary clinical purpose of the Palmaz Balloon Expandable Stent and how is it deployed in the body?

    The Palmaz Balloon Expandable Stent is designed to mechanically expand and maintain the openness of renal arteries, preventing blockages or narrowing (restenosis or occlusion) after angioplasty. It is deployed via a catheter-based approach, where the stent is positioned within the renal artery and expanded using a balloon inflation technique to provide structural support to the vessel wall.

  • Is the Palmaz Balloon Expandable Stent intended for single-use or can it be reused?

    The Palmaz Balloon Expandable Stent is supplied as a single-use device. This means it is intended for one-time use in a patient and should not be reused or reprocessed for subsequent procedures.

  • What type of sterile packaging does the Palmaz Balloon Expandable Stent come in, and what are the recommended storage conditions?

    The Palmaz Balloon Expandable Stent is supplied as a sterile product, ensuring it is ready for immediate use in sterile environments like interventional radiology or cardiology labs. While the exact packaging details are not provided, sterile medical devices like this typically require protection from moisture, extreme temperatures, and direct light. Follow manufacturer guidelines for storage, which may include refrigeration or room-temperature conditions as specified in the accompanying instructions.

  • What regulatory pathway was followed for the approval of the Palmaz Balloon Expandable Stent, and what does this mean for its use?

    The Palmaz Balloon Expandable Stent received FDA Premarket Approval (PMA) under PMA number P890017, which is the highest level of regulatory review for Class III medical devices. This approval indicates that the device has undergone rigorous clinical trials and evaluation to ensure its safety and effectiveness for its intended use in mechanically expanding and maintaining renal artery patency. Clinicians should refer to the approved labeling and manufacturer instructions for proper use.

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No