URYX URETHRAL BULKING AGENT
FDA premarket approval P030030 · decided 2004-12-16
Approval details
- PMA number
- P030030
- Trade name
- URYX URETHRAL BULKING AGENT
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- C.R. Bard, Inc.
- Date received
- 2003-06-23
- Decision date
- 2004-12-16
- Days to decision
- 542 days
- Decision code
- APWD
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Covington, GA
- Statement
- APPROVAL FOR THE URYX URETHRAL BULKING AGENT (URYX). THE DEVICE IS INDICATED FOR TRANSURETHRAL INJECTION IN THE TREATMENT OF ADULT WOMEN DIAGNOSED WITH STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD).
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