Straumann Emdogain
FDA premarket approval P930021/S030 · decided 2023-02-03
Approval details
- PMA number
- P930021
- Supplement
- S030
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Straumann Emdogain
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2023-01-04
- Decision date
- 2023-02-03
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Addition of a second supplier, Eurofins BioPharma Product Testing Sweden AB, for sterility testing (release testing).
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