TEGRESS URETHRAL IMPLANT
FDA premarket approval P030030/S001 · decided 2005-02-09
Approval details
- PMA number
- P030030
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TEGRESS URETHRAL IMPLANT
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- C.R. Bard, Inc.
- Date received
- 2005-01-28
- Decision date
- 2005-02-09
- Days to decision
- 12 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Covington, GA
- Statement
- APPROVAL FOR MODIFICATION OF THE LABELING TO REFLECT A NEW DEVICE TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TEGRESS URETHRAL IMPLANT AND 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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