PMA P980053S007
- Device
- DURASPHERE EXP
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S007
- Product code
- LNM
- Decision date
- 2004-10-27
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- APPROVAL FOR 1 ML SYRINGES WITH SYNTHETIC RUBBER STOPPERS. THESE SYRINGES ARE INTENDED TO STORE DURASPHERE EXP.
Current openFDA PMA Record#
- Device
- DURASPHERE EXP
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S007
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2004-10-27
- Decision code
- APPR
- Date received
- 2004-06-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR 1 ML SYRINGES WITH SYNTHETIC RUBBER STOPPERS. THESE SYRINGES ARE INTENDED TO STORE DURASPHERE EXP.