IMPLANT 60044- PROPEL MINI WITH SDS


Product Overview

IMPLANT 60044
PROPEL - 60044-


Device Description

A bioabsorbable device with a drug coating intended to be implanted into a paranasal sinus (e.g., frontal, sphenoidal, ethmoidal, maxillary) to maintain sinus patency in the treatment of chronic sinusitis. The drug coating is intended to reduce inflammation and polyps to facilitate the separation of sinus mucosal tissues. The device is made of synthetic polymer(s) capable of being degraded and absorbed by body tissues, and is designed to allow for the slow release of the drug coating. It is endoscopically implanted via the nasal passageway; disposable devices associated with implantation may be included.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 15.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OWO

    Device Name: Drug-Eluting Sinus Stent

    Device Class: 3

    Physical State: Resorbable polymer coated in drug

    Definition: Mechanically maintain patency following ethmoid sinus surgery. By also eluting drugs, reduce the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.

    Submission Type ID: 2

    Review Panel: EN

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Delivered through the nostril.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: Sinus

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 20763000710464

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00763000710453

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: PK


    Device Id: 00763000710453

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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