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• 080118 2BE-NTP---- 08EN001-Comment Form-OT4E.pdf
• 080118 2BE-NTP---- 08EN001-Notice of Part 4 Screening-OT4E.pdf
• 080118 2BE-NTP---- Notice of Part 4 Screening-IMLE.pdf
• 080222 2BE-NTP---- 08EN001-Notice of Indication-IEAE.pdf
• 080222 2BE-NTP---- 08EN001-Screening Decision Report-OT5E.pdf