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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 NameCOLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING
Classification Namematerial, dressing, surgical, polylactic acid
Generic Namecollagen wound dressing
ApplicantINTEGRA LIFESCIENCES CORP.
PMA NumberP840062
Supplement NumberS022
Date Received08/18/2011
Decision Date03/19/2012
Product Code
LPG[ Registered Establishments with LPG ]
Advisory Committee Dental
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of an additional trade mame, from oracote, to the collacote absorbable collagen wound dressing for dental surgery products.
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