PMA P980053S009
- Device
- DURASPHERE INJECTABLE BULKING AGENT
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S009
- Product code
- LNM
- Decision date
- 2005-05-25
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- APPROVAL FOR INCLUSION OF THE 5-YEAR POST-MARKET STUDY INFORMATION IN THE DIRECTIONS FOR USE.
Current openFDA PMA Record#
- Device
- DURASPHERE INJECTABLE BULKING AGENT
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S009
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2005-05-25
- Decision code
- APPR
- Date received
- 2005-01-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR INCLUSION OF THE 5-YEAR POST-MARKET STUDY INFORMATION IN THE DIRECTIONS FOR USE.