Straumann Emdogain
FDA premarket approval P930021/S021 · decided 2019-04-23
Approval details
- PMA number
- P930021
- Supplement
- S021
- Supplement type
- 135 Review Track For 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
- 2018-10-22
- Decision date
- 2019-04-23
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- 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
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