DURASPHERE INJECTABLE BULKING AGENT
FDA premarket approval P980053/S004 · decided 2002-07-30
Approval details
- PMA number
- P980053
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DURASPHERE INJECTABLE BULKING AGENT
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Carbon Medical Technologies, Inc.
- Date received
- 2002-02-26
- Decision date
- 2002-07-30
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR THE USE OF GRAPHITE BEAD SUBSTRATE MATERIAL AS AN ALTERNATE TO ZIRCONIUM OXIDE IN THE DEVICE.
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