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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 Namecollagen wound dressing
PMA NumberP840062
Supplement NumberS033
Date Received08/05/2013
Decision Date04/07/2014
Product Code
LPG[ Registered Establishments with LPG ]
Advisory Committee Dental
Supplement Type135 review track for 30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following proposed changes: 1) a new alkaline detergent for use as a cleaning agent; 2) proposed use of total organic carbons (tocs) as a method to test for residues; 3) swab and rinse recovery factors and a visual limit of detection for medical manufacturing area soil on stainless steel and aluminum surfaces; 4) proposed change in equipment dirty hold times (dhts) for the double density hemostatic dispersion, cross-linking process equipment and the mold filling equipment; and 5) proposed installation and operational qualification of a new ultrasonicator.