BARD TEGRESS URETHRAL IMPLANT
FDA premarket approval P030030/S003 · decided 2006-05-23
Approval details
- PMA number
- P030030
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- BARD TEGRESS URETHRAL IMPLANT
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- C.R. Bard, Inc.
- Date received
- 2005-08-29
- Decision date
- 2006-05-23
- Days to decision
- 267 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Covington, GA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE POSTAPPROVAL STUDY PROTOCOL.
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