PMA P930021S030
- Device
- Straumann Emdogain
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S030
- Product code
- NQA
- Decision date
- 2023-02-03
- Generic name
- Biologic material, dental
- Approval order statement
- Addition of a second supplier, Eurofins BioPharma Product Testing Sweden AB, for sterility testing (release testing).
Current openFDA PMA Record#
- Device
- Straumann Emdogain
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S030
- Product code
- NQA
- Generic name
- Biologic material, dental
- Decision date
- 2023-02-03
- Decision code
- OK30
- Date received
- 2023-01-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a second supplier, Eurofins BioPharma Product Testing Sweden AB, for sterility testing (release testing).