PMA P930021S022

Device
Straumann Emdogain
Applicant
The Straumann Company
PMA number
P930021
Supplement
S022
Product code
NQA
Decision date
2019-04-26
Classification
Biologic Material, Dental
Generic name
Biologic material, dental
Approval order statement
Approval to change the test lab for water testing from APL to Mikrolab Stockholm AB

Current openFDA PMA Record#

Device
Straumann Emdogain
Applicant
The Straumann Company
PMA number
P930021
Supplement
S022
Product code
NQA
Generic name
Biologic material, dental
Decision date
2019-04-26
Decision code
APPR
Date received
2018-10-24
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval to change the test lab for water testing from APL to Mikrolab Stockholm AB