IMPLANT 60044- PROPEL MINI WITH SDS

IMPLANT 60044
PROPEL - 60044-

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.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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