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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, COLLAPLUG, COLLATAPE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY
Classification Namematerial, dressing, surgical, polylactic acid
Generic Namecollagen wound dressing
ApplicantINTEGRA LIFESCIENCES CORP.
PMA NumberP840062
Supplement NumberS008
Date Received04/16/2003
Decision Date05/16/2003
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 
Changes affecting manufacturing processes including: 1) qualifying additional manufacturing room, 2) modifying the temperature monitoring method, 3) addition of a different agent for cleansing the manufacturing area, and 4) modifying the method for drying the weighed samples of alkali treated collagen slices.
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