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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDRILAC GRANULES
Classification Namematerial, dressing, surgical, polylactic acid
Generic Namepolylactic acid surgical dressing material
ApplicantKENSEY NASH CORP.
PMA NumberP800012
Supplement NumberS008
Date Received01/31/2002
Decision Date03/05/2002
Product Code
LPG[ Registered Establishments with LPG ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
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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