BARD TEGRESS URETHRAL IMPLANT
FDA premarket approval P030030/S002 · decided 2005-05-27
Approval details
- PMA number
- P030030
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Trade name
- BARD TEGRESS URETHRAL IMPLANT
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- C.R. Bard, Inc.
- Date received
- 2005-05-04
- Decision date
- 2005-05-27
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Covington, GA
- Statement
- APPROVAL FOR A MANUFACTURING SITE AT BARD SHANNON LTD., LAS PIEDRAS, PUERTO RICO, 00771.
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