FDA.reportPublic FDA data

PMA P930021S024

Device
Straumann Emdogain
Applicant
The Straumann Company
Product code
NQA
Decision date
2020-05-15
Generic name
Biologic material, dental
Approval order 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).

Current openFDA PMA Record#

Device
Straumann Emdogain
Applicant
The Straumann Company
PMA number
P930021
Supplement
S024
Product code
NQA
Generic name
Biologic material, dental
Decision date
2020-05-15
Decision code
APPR
Date received
2019-05-29
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order 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).