PMA P930021S023
- Device
- Straumann Emdogain
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S023
- Product code
- NQA
- Decision date
- 2019-06-21
- Classification
- Biologic Material, Dental
- Generic name
- Biologic material, dental
- Approval order statement
- Approval to implement an additional nitrogen gas wash at the end of the ethylene oxide sterilization cycle of the Emdogain product.
Current openFDA PMA Record#
- Device
- Straumann Emdogain
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S023
- Product code
- NQA
- Generic name
- Biologic material, dental
- Decision date
- 2019-06-21
- Decision code
- APPR
- Date received
- 2018-11-02
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to implement an additional nitrogen gas wash at the end of the ethylene oxide sterilization cycle of the Emdogain product.