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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 GEL
Generic NameBiologic material, dental
Regulation Number872.3930
ApplicantThe Straumann Company
60 Minuteman Rd.
Andover, MA 01810
PMA NumberP930021
Supplement NumberS008
Date Received09/13/2002
Decision Date12/02/2003
Product Code NQA 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE FOLLOWING INDICATION FOR USE: "ENDOGAIN GEL IS INDICATED FOR USE IN CORONALLY POSITIONED FLAP PROCEDURES FOR THE TREATMENT OF GINGIVAL RECESSION DEFECTS". THE DEVICE, WITH THIS ADDITIONAL INDICATION FOR USE, WILL BE MARKETED UNDER THE TRADE NAME ENDOGAIN GEL.
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