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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 NumberS027
Date Received06/30/2009
Decision Date02/24/2011
Product Code
MPW[ Registered Establishments with MPW ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for:1) an alternate collagen matrix manufacturing facility within the existing building 3 on thewest lebanon, nh campus;2) minor collagen matrix manufacturing process changes to accommodate a new suite andequipment;3) an alternate collagen matrix container closure;4) collagen matrix release specification changes; and5) use of both tibia and femur bones as starting material for the manufacture of the raw material for collagen matrix component.
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