PMA P980053S005
- Device
- DURASPHERE INJECTABLE BULKING AGENT
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S005
- Product code
- LNM
- Decision date
- 2003-05-28
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- APPROVAL FOR MARKETING DURASPHERE PACKAGED IN 3 ML SYRINGES.
Current openFDA PMA Record#
- Device
- DURASPHERE INJECTABLE BULKING AGENT
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S005
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2003-05-28
- Decision code
- APPR
- Date received
- 2002-11-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR MARKETING DURASPHERE PACKAGED IN 3 ML SYRINGES.