DURASPHERE EXP
FDA premarket approval P980053/S007 · decided 2004-10-27
Approval details
- PMA number
- P980053
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DURASPHERE EXP
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Carbon Medical Technologies, Inc.
- Date received
- 2004-06-29
- Decision date
- 2004-10-27
- Days to decision
- 120 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR 1 ML SYRINGES WITH SYNTHETIC RUBBER STOPPERS. THESE SYRINGES ARE INTENDED TO STORE DURASPHERE EXP.
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