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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 ABSORBABLE COLLAGEN HEMOSTATIC SPONGE & FIBRILLAR FORM
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES CORP.
PMA NumberP850010
Supplement NumberS018
Date Received04/15/2003
Decision Date05/05/2003
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes effecting manufacturing processes including: 1) qualifying additional space in the same facility for the enzyme treatment process using the same dedicated equipment, 2) equipping the alkali treatment processing vessels with a dedicated temperature probe and chart recorder to continuously monitor and record product in the vessels during processing, 3) use of an additional manufacturing area, and 4) using a microwave moisture analyzer, instead of a dry heat oven, for drying the weighted samples of alkali treated collagen slices.
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