BARD TEGRESS URETHRAL IMPLANT
FDA premarket approval P030030/S005 · decided 2007-02-16
Approval details
- PMA number
- P030030
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BARD TEGRESS URETHRAL IMPLANT
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- C.R. Bard, Inc.
- Date received
- 2007-02-02
- Decision date
- 2007-02-16
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Covington, GA
- Statement
- APPROVAL FOR CHANGES TO THE TEGRESS URETHRAL IMPLANT INSTRUCTIONS FOR USE AND PATIENT INFORMATION BROCHURE TO MINIMIZE THE INCIDENCE OF ADVERSE EVENTS (E.G., EROSION AND NECROSIS) AND ENHANCE THE SAFETY OF DEVICE USE.
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