PMA P930021S012

Device
STRAUMANN EMDOGAIN
Applicant
The Straumann Company
PMA number
P930021
Supplement
S012
Product code
NQA
Decision date
2009-08-21
Classification
Biologic Material, Dental
Generic name
Biologic material, dental
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT IBA STERIGENICS WALLONIE, S.A., IN VERVIERS, BELGIUM, FOR THE CONTRACT STERILIZATION OF THE DEVICE.

Current openFDA PMA Record#

Device
STRAUMANN EMDOGAIN
Applicant
The Straumann Company
PMA number
P930021
Supplement
S012
Product code
NQA
Generic name
Biologic material, dental
Decision date
2009-08-21
Decision code
APPR
Date received
2009-01-12
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT IBA STERIGENICS WALLONIE, S.A., IN VERVIERS, BELGIUM, FOR THE CONTRACT STERILIZATION OF THE DEVICE.