Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with…
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- PROPEL FDA PMA
- Generic Name
- Drug-eluting sinus stent FDA PMA
Identifiers
- PMA Number
- P100044 FDA PMA
- FDA Product Code
- OWO FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ear, Nose, Throat FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Propel Sinus Implant is a drug-eluting sinus stent classified as a Drug-Eluting Sinus Stent, designed to maintain patency in the ethmoid sinus following surgery. It separates mucosal tissues, stabilizes the middle turbinate, and prevents obstruction by adhesions while reducing postoperative edema. This intervention aims to decrease the need for additional procedures such as surgical adhesion lysis or oral steroid use.
Intended for use in patients aged 18 and older, the device is supplied sterile and is implanted during ethmoid sinus surgery. It is a single-use, Class III medical device with FDA PMA approval (P100044). The Propel C and SDS variants include specific delivery systems tailored for targeted sinus access. Storage and handling must comply with sterile medical device protocols to ensure efficacy and safety.
Frequently asked questions
What is the Propel Sinus Implant primarily used for in clinical practice, and how does it differ from standard postoperative care for ethmoid sinus surgery?
The Propel Sinus Implant is designed to maintain patency in the ethmoid sinus after surgery by separating mucosal tissues, stabilizing the middle turbinate, and preventing adhesions or obstruction. Unlike standard postoperative care—which may rely on oral steroids or repeated surgical adhesion lysis—this device aims to reduce postoperative edema and the need for additional interventions by providing mechanical support and controlled drug elution. It is specifically intended for patients aged 18 and older following ethmoid sinus surgery.
Are the Propel Sinus Implant and its variants (e.g., Propel Mini or Propel C) reusable, or are they intended for single-use only?
The Propel Sinus Implant, including its variants like the Propel Mini and Propel C (with or without the Straight Delivery System), are explicitly classified as single-use devices. This classification aligns with standard sterile medical device protocols to ensure patient safety and efficacy, as reuse could compromise sterility or performance.
How should the Propel Sinus Implant be stored, and what considerations should clinicians take into account before handling it?
The Propel Sinus Implant is supplied sterile, so storage must adhere to sterile medical device protocols to preserve its integrity. Clinicians should store it in a clean, dry environment away from direct sunlight or extreme temperatures, following manufacturer guidelines to prevent contamination or degradation. Proper handling is critical, as the device is intended for intraoperative use during ethmoid sinus surgery.
What regulatory pathway was followed for FDA approval of the Propel Sinus Implant, and what does this mean for clinicians or hospitals considering its use?
The Propel Sinus Implant received FDA approval through the **Premarket Approval (PMA)** process (PMA number P100044), which is the regulatory pathway for Class III devices. This means the device underwent rigorous clinical evaluation to demonstrate safety and effectiveness for its intended use—maintaining ethmoid sinus patency post-surgery in patients aged 18 and older. Clinicians or hospitals should confirm compliance with the approved labeling and surgical protocols to ensure proper implementation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Electric Skateboard for All-Terrain & Off-Road Riding | Propel EV
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P100044 | Class III | Active |
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Manufacturer
- Manufacturer
- Intersect Ent.
Sources (1)
- FDA PMA P100044 24 fields · synced Sep 18, 2026