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. |
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Trade Name | OP-1 IMPLANT |
Classification Name | filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction |
Generic Name | filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction |
Applicant |
OLYMPUS BIOTECH CORPORATION |
35 south st |
hopkinton, MA 01748 |
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HDE Number | H010002 |
Supplement Number | S001 |
Date Received | 11/07/2001 |
Decision Date | 01/22/2002 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changing the method of analysis for residual host cho cell dna in op-1 protein lots. |
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