Identity
- Trade Name
- DURASPHERE INJECTABLE BULKING AGENT FDA PMA
- Generic Name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE FDA PMA
Identifiers
- PMA Number
- P980053 FDA PMA
- FDA Product Code
- LNM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Durasphere Injectable Bulking Agent is a Class III medical device classified as an Agent, Bulking, Injectable for Gastro-Urology Use. It is designed to provide bulking for tissue in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women, restoring urethral support and improving continence.
Administered via injection, this device is supplied sterile and intended for single-use. It is regulated under an FDA Premarket Approval (PMA) with PMA number P980053 and product code LNM. The agent is manufactured by Carbon Medical Technologies, Inc., and its use is governed by the approved indications outlined in the PMA submission.
Frequently asked questions
What is the Durasphere Injectable Bulking Agent specifically used to treat in adult women?
The Durasphere Injectable Bulking Agent is approved for treating stress urinary incontinence (SUI) caused by intrinsic sphincter deficiency (ISD) in adult women. It works by providing bulking to the urethral tissue, restoring support and improving continence.
Is the Durasphere Injectable Bulking Agent intended for reuse or is it single-use only?
The Durasphere Injectable Bulking Agent is explicitly designed for single-use only, as stated in its description. This ensures sterility and safety for each patient treatment.
How is the Durasphere Injectable Bulking Agent administered, and what form does it come in?
The Durasphere Injectable Bulking Agent is administered via injection. It is supplied sterile and in a form ready for direct injection into the urethral tissue to provide bulking.
What regulatory pathway does the Durasphere Injectable Bulking Agent follow, and what is its PMA number?
The Durasphere Injectable Bulking Agent follows the FDA Premarket Approval (PMA) pathway, with the PMA number **P980053**. This indicates it has undergone rigorous review and approval for its intended use.
Are there multiple sizes or models of the Durasphere Injectable Bulking Agent, and how would I identify them?
Yes, the Durasphere Injectable Bulking Agent comes in multiple sizes or models, each identified by a unique FEI number (e.g., 3014909464, 3002968685, etc.). These numbers are listed under the OpenFDA specifications and help distinguish different batches or formulations.
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 | P980053 | Class III | Active |
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Manufacturer
- Manufacturer
- Carbon Medical Technologies, Inc.
Sources (1)
- FDA PMA P980053 24 fields · synced Oct 6, 2026