PMA P980053S019
- Device
- Durasphere Injectable Bulking Agent
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S019
- Product code
- LNM
- Decision date
- 2022-10-27
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- Change in the sterilization process parameters within the existing sterilization facility.
Current openFDA PMA Record#
- Device
- Durasphere Injectable Bulking Agent
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S019
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2022-10-27
- Decision code
- OK30
- Date received
- 2022-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the sterilization process parameters within the existing sterilization facility.