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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 DENTAL BONE GRAFTING MATERIAL WITH BIOLOGIC COMPONENT
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 NumberS008
Date Received08/30/2006
Decision Date10/05/2006
Withdrawal Date02/16/2016
Product Code NPZ 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, US, LLC, QUEENSBURY, NEW YORK, TO PERFORM THE ETHYLENE OXIDE STERILIZATION.
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