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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 NumberS026
Date Received04/18/2008
Decision Date09/17/2008
Product Code
MPW[ Registered Establishments with MPW ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for final printed labeling and for modifications to the "preparation for use" section of the package insert to address concerns associated with apreviously unapproved change in the amount of fluid used to reconstitute the lyophilized op- i component from ". 2. 5cc. " to ". 2-3cc. ". This section of the package insert now correctly states that 2. 5cc of fluid must be used to reconstitute the op-l component.
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