PMA P980053S006
- Device
- DURASPHERE EXP
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S006
- Product code
- LNM
- Decision date
- 2003-08-26
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order 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).
Current openFDA PMA Record#
- Device
- DURASPHERE EXP
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S006
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2003-08-26
- Decision code
- APPR
- Date received
- 2003-03-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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).