Identity
- Trade Name
- DEFLUX INJECTABLE GEL FDA PMA
- Generic Name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE FDA PMA
Identifiers
- PMA Number
- P000029 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
Deflux Injectable Gel is a bulking agent for injectable use in gastro-urology, classified as a Class III medical device. It is specifically designed to treat vesicoureteral reflux (VUR) grades II–IV in pediatric patients by reinforcing the ureteral submucosa, thereby reducing or eliminating reflux.
The device is supplied as a sterile, single-use injectable gel and is regulated under an FDA Premarket Approval (PMA). It is administered via cystoscopic injection under direct visualization, with no MRI safety restrictions noted. Storage and handling must comply with sterile medical device protocols, and its use is restricted to qualified urologists in clinical settings.
Frequently asked questions
What is Deflux Injectable Gel used to treat in pediatric patients and how does it work?
Deflux Injectable Gel is specifically designed to treat vesicoureteral reflux (VUR) grades II–IV in children. It works as a bulking agent by reinforcing the ureteral submucosa during cystoscopic injection, which helps reduce or eliminate reflux by physically supporting the ureteral wall.
Is Deflux Injectable Gel single-use or reusable, and how should it be stored?
Deflux Injectable Gel is supplied as a sterile, single-use injectable gel. Since it is sterile, it must be stored and handled according to standard sterile medical device protocols to maintain its integrity and safety for use.
Who is authorized to administer Deflux Injectable Gel, and where is it used?
Deflux Injectable Gel is restricted for use by qualified urologists in clinical settings. It is administered via cystoscopic injection under direct visualization, ensuring precise placement for treating pediatric VUR.
Are there any special considerations for imaging or safety when using Deflux Injectable Gel?
Deflux Injectable Gel does not have any noted MRI safety restrictions, meaning it can be used in patients who require MRI scans without interference. However, it is only administered in controlled clinical settings.
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 | P000029 | Class III | Active |
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Manufacturer
- Manufacturer
- Palette Life Sciences
Sources (1)
- FDA PMA P000029 24 fields · synced Sep 18, 2026