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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 NameHELISTAT HELITENSE ABSORBABLE COLLLAGENHEMOSTATIC AGENT MICROFIBRILLAR FORM
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES CORPORATION
PMA NumberP850010
Supplement NumberS046
Date Received11/04/2013
Decision Date03/18/2014
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 Yes
Approval Order Statement 
Approval for adding increased system capacity for water purification of the current reverse osmosis/electro-deionization water purification system (roedi).
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