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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.
 
DeviceEMDOGAIN
Generic NameBiologic material, dental
Regulation Number872.3930
ApplicantThe Straumann Company
60 Minuteman Rd.
Andover, MA 01810
PMA NumberP930021
Supplement NumberS004
Date Received03/09/2000
Decision Date01/19/2001
Product Code NQA 
Advisory Committee Dental
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO CHANGE FROM THE EMDOGAIN(R) TWO VIAL SYSTEM TO THE EMOGAIN(R) GEL FILLED STERILE SYRINGES.
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