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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 PUTTY FOR POSTEROLATERAL SPINAL FUSIONS
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 s. st.
hopkinton, MA 01748
HDE NumberH020008
Supplement NumberS001
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 
Approval for several changes to the manufacturing of op-1. Specifically, you proposed implementing process 3 7c which includes the following modifications:1) replacing fetal bovine serum (fbs) with gamma irradiated fi3s;2) replacing lipid manufactured from hydrolyzed lecithin with··. Chemically defined lipid mixture. "; and3) replacing bovine insulin with recombinant human insulin.
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