Mentor Saline-Filled Testicular Prosthesis
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS FDA PMA
- Generic Name
- Prosthesis, testicular FDA PMA
Identifiers
- PMA Number
- P020003 FDA PMA
- FDA Product Code
- FAF FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 876.3750 FDA PMA
- Regulation Number
- 876.3750 FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Mentor Saline-Filled Testicular Prosthesis is a medical device designed for cosmetic testicular replacement. It is indicated for use when a patient requires cosmetic restoration due to testicular agenesis or following surgical removal of a testicle.
This prosthesis is manufactured by Coloplast Corp. and is available in various sizes to accommodate individual patient needs. The device has received FDA PMA and MDR authorizations, ensuring it meets regulatory standards for safety and effectiveness.
Frequently asked questions
What is the Mentor Saline-Filled Testicular Prosthesis used for?
The Mentor Saline-Filled Testicular Prosthesis is specifically designed for cosmetic testicular replacement. It is indicated for use in cases of testicular agenesis (congenital absence) or following the surgical removal of a testicle, providing patients with a natural-looking appearance.
What sizes are available for the Mentor Saline-Filled Testicular Prosthesis?
The Mentor Saline-Filled Testicular Prosthesis is manufactured in various sizes to accommodate individual patient needs. While specific size dimensions are not provided in the device data, the availability of multiple sizes ensures proper fit and cosmetic results for different patients.
What regulatory approvals has the Mentor Saline-Filled Testicular Prosthesis received?
The Mentor Saline-Filled Testicular Prosthesis has received FDA PMA (Pre-Market Approval) and MDR (Medical Device Reporting) authorizations. These regulatory approvals indicate that the device has been evaluated by the appropriate authorities and meets the necessary safety and effectiveness requirements for its intended use.
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: Torosa Saline-Filled Testicular Prosthesis - Coloplast, P020003 - Premarket Approval (PMA) - FDA, Testicular replacement - Coloplast US, Advances and Clinical Applications of Testicular Prostheses, Testicular prosthesis and method of manufacturing and filling
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | European Union | MDR | — | Class III | Pending data |
| FDA PMA | United States | FDA_PMA | P020003 | Class III | Active |
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Manufacturer
- Manufacturer
- Coloplast Corp.
Sources (1)
- FDA PMA P020003 24 fields · synced Sep 18, 2026