Identity
- Trade Name
- TITAN INFLATABLE PENILE PROSTHESIS FDA PMA
- Generic Name
- Device, impotence, mechanical/hydraulic FDA PMA
Identifiers
- PMA Number
- P000006 FDA PMA
- FDA Product Code
- FHW FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 876.3350 FDA PMA
- Regulation Number
- 876.3350 FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Titan Inflatable Penile Prosthesis is a mechanical/hydraulic device classified as a penile prosthesis, designed for male patients suffering from erectile dysfunction. It is intended for implantation to restore erectile function through an inflatable mechanism, providing a solution for those who are candidates for prosthetic intervention.
This device is supplied sterile and intended for single-use implantation by a qualified surgeon in an operating room setting. It is regulated under FDA PMA approval (PMA P000006) and falls under device class III. The prosthesis is available in specific model variants as referenced in the product codes and must be handled and stored according to manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What types of patients is the Titan Inflatable Penile Prosthesis intended for, and how is it implanted?
The Titan Inflatable Penile Prosthesis is designed for male patients suffering from erectile dysfunction who are considered candidates for penile prosthesis implantation. It is intended to be surgically implanted by a qualified surgeon in an operating room setting to restore erectile function through an inflatable mechanism.
Is the Titan Inflatable Penile Prosthesis reusable, and how should it be stored to maintain sterility?
The Titan Inflatable Penile Prosthesis is supplied sterile and intended for **single-use implantation only**. To maintain sterility and functionality, it must be handled and stored according to the manufacturer’s guidelines, which likely include keeping it in its original packaging until use.
What regulatory approval does this device hold, and how does that affect its availability?
The Titan Inflatable Penile Prosthesis holds **FDA PMA approval (PMA P000006)**, meaning it has undergone rigorous review and is classified as a **Class III device** under FDA regulations. This approval ensures it meets strict safety and effectiveness standards before being made available for clinical use in the U.S.
Are there different model variants available for the Titan Inflatable Penile Prosthesis, and how would I determine the correct size?
Yes, the Titan Inflatable Penile Prosthesis comes in **specific model variants**, as referenced by its product codes (e.g., FHW). The correct size is determined by a surgeon based on the patient’s anatomy and clinical assessment, ensuring proper fit and function during implantation.
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 | P000006 | Class III | Active |
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Manufacturer
- Manufacturer
- Coloplast Corp.
Sources (1)
- FDA PMA P000006 24 fields · synced Sep 18, 2026