Straumann Emdogain
FDA premarket approval P930021/S024 · decided 2020-05-15
Approval details
- PMA number
- P930021
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Straumann Emdogain
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2019-05-29
- Decision date
- 2020-05-15
- Days to decision
- 352 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Approval for adding two new packaging configurations branded as Emdogain® MI (design change), adding an alternate application needle (cannula) design for the two new packaging configurations (design change), and updating the name of the Supplier for the applicable needle (cannula) (Supplier name change).
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