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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 ENDOGAIN, 0.15 ML, 075.099, STRAUMANN ENDOGAIN, 0.3 ML, 075.113, STRAUMANN ENDOGAIN, 0.7 ML, 075.115
Classification Namebiologic material, dental
Generic Namebiologic material, dental
Regulation Number872.3930
Applicant
THE STRAUMANN COMPANY
60 minuteman road
andover, MA 01810
PMA NumberP930021
Supplement NumberS013
Date Received09/19/2012
Decision Date07/02/2013
Product Code
NQA[ Registered Establishments with 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 Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDEON SCIENCE PARK, MALMO, SWEDEN.
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