CZM weren't relying on substantial equivalence for approval. They would have used a different pathway for a new device right from the start. It's one reason it took years for Convivo to get approval. But as a big company with years of experience getting approval for imaging devices, they knew exactly what they had to do.
Ann: Optiscan Intends to pursue De Novo Pathway for InVivage, page-25
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Last
13.5¢ |
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| Open | High | Low | Value | Volume |
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| Last trade - 16.10pm 05/06/2024 (20 minute delay) ? |
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Last
13.5¢ |
Change
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| Open | High | Low | Volume | ||
| 13.0¢ | 14.5¢ | 12.5¢ | 712453 | ||
| Last updated 15.57pm 05/06/2024 ? | |||||
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