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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 HDE to get an up-to-date view of this device.
 
Trade NameOP-1 IMPLANT
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Generic Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Applicant
OLYMPUS BIOTECH CORPORATION
35 south st
hopkinton, MA 01748
HDE NumberH010002
Supplement NumberS014
Date Received08/05/2004
Decision Date02/22/2005
Product Code
MPW[ Registered Establishments with MPW ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Several changes to manufacturing of op-1, specficially, implementing process37c which includes:- replacing fetal bovine serum (fbs) with gamma irradiated fbs- replacing lipid manufactured from hydorlyzed lecithin with ". Chemicallydefined lipid mixute. " and- replacing bovine insulin with recombinant human insulin.
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