DURASPHERE INJECTABLE BULKING AGENT
FDA premarket approval P980053/S009 · decided 2005-05-25
Approval details
- PMA number
- P980053
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DURASPHERE INJECTABLE BULKING AGENT
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Carbon Medical Technologies, Inc.
- Date received
- 2005-01-06
- Decision date
- 2005-05-25
- Days to decision
- 139 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR INCLUSION OF THE 5-YEAR POST-MARKET STUDY INFORMATION IN THE DIRECTIONS FOR USE.
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