PMA P930021S017
- Device
- STRAUMANN EMDOGAIN
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S017
- Product code
- NQA
- Decision date
- 2017-02-17
- Classification
- Biologic Material, Dental
- Generic name
- Biologic material, dental
- Approval order statement
- Approval for design changes to the syringe packaging and manufacturing changes for in-house secondary packaging by Biora AB.
Current openFDA PMA Record#
- Device
- STRAUMANN EMDOGAIN
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S017
- Product code
- NQA
- Generic name
- Biologic material, dental
- Decision date
- 2017-02-17
- Decision code
- APPR
- Date received
- 2016-09-09
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for design changes to the syringe packaging and manufacturing changes for in-house secondary packaging by Biora AB.