Contigen (TM) Bard (R) Collagen Implant

FDA premarket approval P900030 · Agent, Bulking, Injectable for Gastro-Urology Use

PMA numberP900030

Approval

Applicant
Allergan, Inc.
Received
April 27, 1990
Decision date
September 30, 1993 (APWD)
Supplements
9, latest October 2, 2009
Product code
LNM – Agent, Bulking, Injectable For Gastro-Urology Use

Official FDA PMA record

Approval order statement

Approval for the Contigen™ Bard® Collagen Implant. This device is indicated for use in the treatment of urinary incontinence due to intrinsic sphincter deficiency (poor or non-functioning bladder outlet mechanism) that may be helped by a locally injected bulking agent. Contigen implant therapy is intended only for patients who have shown no improvement in their incontinence for at least 12 months.