PMA P980053S017
- Device
- Durasphere Injectable Bulking Agent
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S017
- Product code
- LNM
- Decision date
- 2019-08-29
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- New vendor to supply the glucan powder for the subject device.
Current openFDA PMA Record#
- Device
- Durasphere Injectable Bulking Agent
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S017
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2019-08-29
- Decision code
- OK30
- Date received
- 2019-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New vendor to supply the glucan powder for the subject device.