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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, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS
Classification Namematerial, dressing, surgical, polylactic acid
Generic Namecollagen wound dressing
ApplicantINTEGRA LIFESCIENCES CORP.
PMA NumberP840062
Supplement NumberS024
Date Received08/31/2012
Decision Date09/28/2012
Product Code
LPG[ Registered Establishments with LPG ]
Advisory Committee Dental
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Upgrades to the medical products manufacturing suite.
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