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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.
 
DevicePURE-DENT B851 ABSORBABLE DUSTING POWDER
Generic NamePowder, dusting, surgical
ApplicantGrain Processing Corp.
1600 Oregon St.
Muscatine, IA 52761
PMA NumberP890070
Supplement NumberS005
Date Received02/17/2011
Decision Date10/07/2011
Withdrawal Date12/28/2015
Product Code KGP 
Advisory Committee General Hospital
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 PACMOORE PROCESS TECHNOLOGIES, LLC. IN MOORESVILLE, INDIANA.
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