STRAUMANN EMDOGAIN
FDA premarket approval P930021/S017 · decided 2017-02-17
Approval details
- PMA number
- P930021
- Supplement
- S017
- 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
- 2016-09-09
- Decision date
- 2017-02-17
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Approval for design changes to the syringe packaging and manufacturing changes for in-house secondary packaging by Biora AB.
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