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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 NameCOLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS-MICROFIBRILLAR FORM, COLLASTAT ABSORABLE COLAGEN HEMOSTATIC SPONGE
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable collagen hemostatic agents
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES
PMA NumberP810006
Supplement NumberS053
Date Received04/11/2014
Decision Date10/17/2014
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the implementation of mechanical, program, and system control changes to the existing chilled water system that services collagen lyophilizer machines in the lyo manufacturing area of building 1 at the integra neurosciences facility in añasco, puerto rico, for the devices.
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