- Device
- Straumann Emdogain
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S021
- Product code
- NQA
- Generic name
- Biologic material, dental
- Decision date
- 2019-04-23
- Decision code
- APPR
- Date received
- 2018-10-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to change the test method for determining the calcium content of the intermediate bulk product and outsource the calcium content testing to Toxicon AB