- Device
- Durasphere Injectable Bulking Agent
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S018
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2021-02-25
- Decision code
- APPR
- Date received
- 2020-12-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Steris, 9303 West Broadway Ave., Brooklyn Park, MN 55445, a contract sterilizer.