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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 Rd.
Andover, MA 01810
PMA NumberP930021
Supplement NumberS029
Date Received10/17/2022
Decision Date11/16/2022
Product Code NQA 
Advisory Committee Dental
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Improved settings for HPLC identification (ID) method for Emdogain (test method for in-process control and final release testing);2) Removal of redundant Acetic acid content determination (release testing);3) Removal of one redundant Calcium concentration determination (in-process control); and4) Removal of redundant sampling step on Emdogain gel bulk(in-process control.
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