- Device
- Staumann Emdogain
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S025
- Product code
- NQA
- Generic name
- Biologic material, dental
- Decision date
- 2019-09-03
- Decision code
- OK30
- Date received
- 2019-08-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updating the environmental monitoring program; relocating the doors to a refrigerator and freezer (moved from one wall to another); and introducing a cutting tool and changed tolerance for seal strength test strips