DURASPHERE EXP
FDA premarket approval P980053/S006 · decided 2003-08-26
Approval details
- PMA number
- P980053
- Supplement
- S006
- 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
- 2003-03-07
- Decision date
- 2003-08-26
- Days to decision
- 172 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR A MODIFIED BEAD SPECIFICATION (90-212 UM) FOR THE PYROLYTIC CARBON COATED ZIRCONIUM OXIDE AND GRAPHITE BEADS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DURASPHERE EXP AND IS INDICATED FOR USE IN THE TREATMENT OF ADULT WOMEN WITH STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD).
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| Endoscopic Injection Needle (K172227) | Carbon Medical Technologies, Inc. | 2017-08-23 |
| BIOMARC COAXIAL NEEDLE (K133148) | Carbon Medical Technologies, Inc. | 2014-05-13 |
| BIOMARC FIDUCIAL MARKER (K132064) | Carbon Medical Technologies, Inc. | 2014-02-28 |
| BIOMARC FIDUCIAL MARKER (K132708) | Carbon Medical Technologies, Inc. | 2013-12-20 |
| BIOMARC GOLD FIDUCIAL MARKER (K130678) | Carbon Medical Technologies, Inc. | 2013-04-12 |