PMA P980053S021
- Device
- Durasphere Injectable Bulking Agent
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S021
- Product code
- LNM
- Decision date
- 2026-03-13
- Classification
- Gastroenterology, Urology
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- a change to the syringe cap of the 1 mL Durasphere device configuration
Current openFDA PMA Record#
- Device
- Durasphere Injectable Bulking Agent
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S021
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2026-03-13
- Decision code
- APPR
- Date received
- 2025-01-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- a change to the syringe cap of the 1 mL Durasphere device configuration