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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSTRAUMANN EMDOGAIN
Generic NameBiologic material, dental
Regulation Number872.3930
ApplicantTHE STRAUMANN COMPANY
60 Minuteman Road
Andover, MA 01810
PMA NumberP930021
Supplement NumberS012
Date Received01/12/2009
Decision Date08/21/2009
Product Code NQA 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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.
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