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Trade Name | OP-1 PUTTY FOR POSTEROLATERAL SPINAL FUSIONS |
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 | H020008 |
Supplement Number | S001 |
Date Received | 08/05/2004 |
Decision Date | 02/22/2005 |
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 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. |