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 | S012 |
Date Received | 03/05/2004 |
Decision Date | 04/15/2004 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Widening of specification for bioburden of the bone powder to manufacture collagen matrix from = 1. 1 mpn/gram to = 3. 7 mpn/gram. |
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