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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.
Classification Namematerial, dressing, surgical, polylactic acid
Generic Namepolylactic acid surgical dressing material
PMA NumberP800012
Supplement NumberS009
Date Received08/12/2002
Decision Date09/17/2002
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 new manufacturing and sterilization sites. The manufacturing site is located at kensey nash corporation, exton, pa. The new sterilization site is located at steris isomedix services, whippany, nj.