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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, COLLATAPE, AND COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY
Classification Namematerial, dressing, surgical, polylactic acid
Generic Namecollagen wound dressing
ApplicantINTEGRA LIFESCIENCES
PMA NumberP840062
Supplement NumberS029
Date Received05/21/2013
Decision Date06/20/2013
Product Code
LPG[ Registered Establishments with LPG ]
Advisory Committee Dental
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of a replacement portable chiller.
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