PMA P980053S015
- Device
- DURASPHERE INJECTABLE BULKING AGENT
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S015
- Product code
- LNM
- Decision date
- 2013-08-19
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- ADDITION OF A NEW TEXTURE ANALYZER SYSTEM.
Current openFDA PMA Record#
- Device
- DURASPHERE INJECTABLE BULKING AGENT
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S015
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2013-08-19
- Decision code
- OK30
- Date received
- 2013-07-22
- Supplement type
- 30-Day Notice
- Approval order statement
- ADDITION OF A NEW TEXTURE ANALYZER SYSTEM.