PMA P980053S008
- Device
- DURASPHERE INJECTABLE BULKING AGENT
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S008
- Product code
- LNM
- Decision date
- 2005-09-26
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- APPROVAL FOR THE 1 ML SYRINGE USED TO DEPLOY DURASPHERE INJECTABLE BULKING AGENT TO BE CHANGED FROM A POLYCARBONATE SYRINGE WITH THE LATEX-FREE COMPOUND TIP TO A SYRINGE WITH A POLYPROPYLENE SILICONE TIP.
Current openFDA PMA Record#
- Device
- DURASPHERE INJECTABLE BULKING AGENT
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S008
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2005-09-26
- Decision code
- APPR
- Date received
- 2004-12-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE 1 ML SYRINGE USED TO DEPLOY DURASPHERE INJECTABLE BULKING AGENT TO BE CHANGED FROM A POLYCARBONATE SYRINGE WITH THE LATEX-FREE COMPOUND TIP TO A SYRINGE WITH A POLYPROPYLENE SILICONE TIP.