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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, AND PEPGEN P-15 PUTTY
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 NumberS005
Date Received11/12/2003
Decision Date03/15/2004
Withdrawal Date02/16/2016
Product Code NPZ 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR: 1) THE ADDITION OF A PASTE FORM OF PEPGEN P-15, 2) MODIFICATION OF THE DEVICE LABELING FOR ALL PEPGEN P-15 DEVICES, AND 3) CHANGING OF THE CONTRACT MANUFACTURER FOR THE DEVICE CARRIER TO HYALURON, INC., WOBURN, MASSACHUSETTS.
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