PMA P980053S004
- Device
- DURASPHERE INJECTABLE BULKING AGENT
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S004
- Product code
- LNM
- Decision date
- 2002-07-30
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- APPROVAL FOR THE USE OF GRAPHITE BEAD SUBSTRATE MATERIAL AS AN ALTERNATE TO ZIRCONIUM OXIDE IN THE DEVICE.
Current openFDA PMA Record#
- Device
- DURASPHERE INJECTABLE BULKING AGENT
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S004
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2002-07-30
- Decision code
- APPR
- Date received
- 2002-02-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF GRAPHITE BEAD SUBSTRATE MATERIAL AS AN ALTERNATE TO ZIRCONIUM OXIDE IN THE DEVICE.