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Contigen Bard Collagen Implant

FDA PMA

Class III (US FDA PMA)

PMA P900030

by Allergan, Inc.

Identity

Trade Name
CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT FDA PMA
Generic Name
AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE FDA PMA

Identifiers

PMA Number
P900030 FDA PMA
FDA Product Code
LNM FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Gastroenterology, Urology FDA PMA
FDA Decision
APWD FDA PMA

The Contigen Bard Collagen Implant is an injectable bulking agent classified under the nomenclature ‘Agent, Bulking, Injectable for Gastro-Urology Use.’ It is designed to treat urinary incontinence caused by intrinsic sphincter deficiency, where a non-functioning bladder outlet mechanism may be improved through local injection of a bulking substance. This therapy is intended for patients who have not responded to conservative treatments for at least 12 months.

This device is supplied as a sterile, single-use injectable implant and is regulated under FDA Premarket Approval (PMA P900030). It is intended for urological use and requires proper handling and storage as a medical implant. The product is categorized under device class III, reflecting its higher regulatory oversight due to its clinical significance in managing incontinence. No additional regulatory status beyond the stated PMA is implied.

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

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Allergan, Inc.

Sources (1)

  • FDA PMA P900030 23 fields · synced Sep 18, 2026