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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 NameCOLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
Classification Namematerial, dressing, surgical, polylactic acid
Generic Namecollagen wound dressing
ApplicantINTEGRA LIFESCIENCES
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.
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