Identity
- Trade Name
- MENTOR POLYTEF PASTE FOR INJECTION FDA PMA
- Generic Name
- PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION FDA PMA
Identifiers
- PMA Number
- N16420 FDA PMA
- FDA Product Code
- LTG FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Dental FDA PMA
- FDA Decision
- APWD FDA PMA
The Mentor Polytetrafluoroethylene Paste for Injection is an injectable paste designed for vocal cord augmentation. Classified as a Paste, Injectable for Vocal Cord Augmentation, it is composed of polytetrafluoroethylene (PTFE) particles suspended in a biocompatible carrier, intended to restore vocal cord mobility and improve voice quality in patients with vocal cord paralysis or atrophy.
This device is supplied as a sterile, single-use paste for direct injection into the vocal cords under endoscopic guidance. It is regulated under FDA_PMA (PMA Number N16420) and falls under Device Class 3, requiring premarket approval. Storage and handling must adhere to sterile medical practice protocols to maintain integrity prior to use.
Frequently asked questions
What is the Mentor Polytetrafluoroethylene Paste for Injection used for in clinical practice?
The Mentor Polytetrafluoroethylene Paste for Injection is specifically designed to restore vocal cord mobility and improve voice quality in patients suffering from vocal cord paralysis or atrophy. It is injected directly into the vocal cords under endoscopic guidance to provide augmentation.
Is the Mentor Polytetrafluoroethylene Paste for Injection intended for reuse or is it single-use?
The Mentor Polytetrafluoroethylene Paste for Injection is explicitly labeled as a **sterile, single-use** product. This ensures patient safety and maintains sterility standards for medical procedures, requiring a new application per patient.
How should the Mentor Polytetrafluoroethylene Paste for Injection be stored before use?
Since it is a sterile medical device, storage must follow standard sterile medical practice protocols to preserve its integrity. While the exact storage conditions (e.g., temperature) are not detailed here, it is critical to avoid contamination and maintain the sealed packaging until immediate use.
What regulatory pathway does the Mentor Polytetrafluoroethylene Paste for Injection follow?
The device is regulated under the **FDA Premarket Approval (PMA)** pathway, indicated by its PMA number (N16420). This classification (Device Class 3) requires rigorous review to ensure safety and effectiveness before market authorization, as it is intended for direct injection into human tissue.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | N16420 | Class III | Active |
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Manufacturer
- Manufacturer
- Coloplast Corp.
Sources (1)
- FDA PMA N16420 23 fields · synced Sep 18, 2026