PMA P980053S020
- Device
- Durasphere® Injectable Bulking Agent
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S020
- Product code
- LNM
- Decision date
- 2024-01-18
- Classification
- Gastroenterology, Urology
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- changes to the sterilization parameters
Current openFDA PMA Record#
- Device
- Durasphere® Injectable Bulking Agent
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S020
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2024-01-18
- Decision code
- OK30
- Date received
- 2023-12-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the sterilization parameters