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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.
 
DeviceDRILAC GRANULES
Generic NameMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
ApplicantOsmed, Inc.
325 Lake Ave. S. - Suite
#608
Duluth, MN 55802
PMA NumberP800012
Supplement NumberS008
Date Received01/31/2002
Decision Date03/05/2002
Withdrawal Date04/25/2007
Product Code LPG 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT KENSEY NASH CORPORATION, EXTON, PENNSYLVANIA. THE GRANULATION AND SYRINGE CUTTING PROCESSES WILL BE CONDUCTED AT THIS FACILITY.
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