- Device
- Straumann Emdogain
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S028
- Product code
- NQA
- Generic name
- Biologic material, dental
- Decision date
- 2023-04-04
- Decision code
- APPR
- Date received
- 2021-12-10
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the implementation of a new freeze room and a new cold room to increase storage capacity for raw materials, and intermediate and final products.