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• 110223 3BC-CVF---- 11YN005-Notice of Part 4 Screening and Comment Request-OT5E.pdf
• 110318 3BC-CVF----11YN005-NOTICE OF INDICATION-OA2E.pdf
• 110318 3BC-CVF----11YN005-Screening Decision Report-OT5E.pdf
• 140331 3BC-CVF1111 11YN005-Notice of Indication-OA2E.pdf
• 140331 3BC-CVF1111 11YN005-Screening Decision Report-OT3E.pdf