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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.
 
DevicePEPGEN P-15/PEPGEN P-15 FLOW
Generic NameBone grafting material, dental, with biologic component
Regulation Number872.3930
ApplicantCeramed Corp.
12860 W. Cedar Dr.,
Suite 108
Lakewood, CO 80228
PMA NumberP990033
Supplement NumberS003
Date Received01/14/2002
Decision Date01/25/2002
Withdrawal Date02/16/2016
Product Code NPZ 
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  
CHANGE IN MANUFACTURER/VENDOR FOR THE P-15 PEPTIDE.
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