Identity
- Trade Name
- SOLESTA INJECTABLE GEL FDA PMA
- Generic Name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE FDA PMA
Identifiers
- PMA Number
- P100014 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
Solesta Injectable Gel is an agent, bulking, injectable for gastro-urology use. It is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy such as diet, fiber therapy, or anti-motility medications.
The device is supplied as an injectable gel and is intended for use under medical supervision. It is a single-use product, and its authorization is based on FDA PMA approval (P100014). No information on sterility, MRI safety, sizes, or storage is provided in the data.
Frequently asked questions
What is Solesta Injectable Gel used for?
Solesta Injectable Gel is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy, such as diet, fiber therapy, or anti-motility medications, as stated in the approval documentation.
Who manufactures Solesta Injectable Gel?
Solesta Injectable Gel is manufactured by Palette Life Sciences, as specified in the manufacturer and applicant fields of the device data.
Is Solesta Injectable Gel approved by the FDA?
Yes, Solesta Injectable Gel has received FDA PMA approval, with the authorization listed as FDA_PMA and the PMA number P100014 in the device data.
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 | P100014 | Class III | Active |
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Manufacturer
- Manufacturer
- Palette Life Sciences
Sources (1)
- FDA PMA P100014 24 fields · synced Sep 18, 2026