PMA P930021S027

Device
Straumann Emdogain
Applicant
The Straumann Company
PMA number
P930021
Supplement
S027
Product code
NQA
Decision date
2021-02-22
Generic name
Biologic material, dental
Approval order statement
Replacement of the current centrifuge used in the manufacture of Emdogain with a new centrifuge.

Current openFDA PMA Record#

Device
Straumann Emdogain
Applicant
The Straumann Company
PMA number
P930021
Supplement
S027
Product code
NQA
Generic name
Biologic material, dental
Decision date
2021-02-22
Decision code
OK30
Date received
2021-01-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replacement of the current centrifuge used in the manufacture of Emdogain with a new centrifuge.