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22-B10600
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SCOPE
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7/12/2013
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22-B10601
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PURPOSE
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7/12/2013
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22-B10602
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CONFIDENTIALITY OF DATA AND INFORMATION IN A PREMARKET APPROVAL APPLICATION (PMA) FILE
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7/12/2013
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22-B10603
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RESEARCH CONDUCTED OUTSIDE OF THE UNITED STATES
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7/12/2013
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22-B10604
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SERVICE OF ORDERS
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7/12/2013
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22-B10605
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PRODUCT DEVELOPMENT PROTOCOL (PDP)
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7/12/2013
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22-B10606
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APPLICATION
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7/12/2013
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22-B10607
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PREMARKET APPROVAL APPLICATION AMENDMENTS AND RESUBMITTED PREMARKET APPROVAL APPLICATION
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7/12/2013
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22-B10608
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PREMARKET APPROVAL APPLICATION SUPPLEMENTS
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7/12/2013
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22-B10609
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TIME FRAME FOR REVIEWING A PREMARKET APPROVAL APPLICATION
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7/12/2013
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22-B10610
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FILING A PREMARKET APPROVAL APPLICATION
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7/12/2013
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22-B10611
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PROCEDURES FOR REVIEW OF A PREMARKET APPROVAL APPLICATION
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7/12/2013
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22-B10612
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DENIAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION
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7/12/2013
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22-B10613
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WITHDRAWAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION
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7/12/2013
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22-B10614
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TEMPORARY SUSPENSION OF APPROVAL OF A PREMARKET APPROVAL APPLICATION
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7/12/2013
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22-B10615
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GENERAL
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7/12/2013
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22-B10616
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POST-APPROVAL REQUIREMENTS
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7/12/2013
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22-B10617
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REPORTS
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7/12/2013
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22-B10618
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PURPOSE AND SCOPE
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7/12/2013
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22-B10619
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DESIGNATION OF HUMANITARIAN USE DEVICES STATUS
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7/12/2013
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22-B10620
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ORIGINAL APPLICATIONS
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7/12/2013
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22-B10621
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HUMANITARIAN DEVICE EXEMPTION AMENDMENTS AND RESUBMITTED HUMANITARIAN DEVICE EXEMPTIONS
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7/12/2013
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22-B10622
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SUPPLEMENTAL APPLICATIONS
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7/12/2013
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22-B10623
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NEW INDICATIONS FOR USE
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7/12/2013
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22-B10624
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FILING A HUMANITARIAN DEVICE EXEMPTION
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7/12/2013
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22-B10625
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TIME FRAMES FOR REVIEWING A HUMANITARIAN DEVICE EXEMPTION
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7/12/2013
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22-B10626
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PROCEDURES FOR REVIEW OF A HUMANITARIAN DEVICE EXEMPTION
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7/12/2013
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22-B10627
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DENIAL OF APPROVAL OR WITHDRAWAL OF APPROVAL OF A HUMANITARIAN DEVICE EXEMPTION
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7/12/2013
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22-B10628
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TEMPORARY SUSPENSION OF APPROVAL OF A HUMANITARIAN DEVICE EXEMPTION
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7/12/2013
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22-B10629
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CONFIDENTIALITY OF DATA AND INFORMATION
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7/12/2013
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22-B10630
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[RESERVED]
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7/12/2013
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22-B10631
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INSTITUTIONAL REVIEW BOARD REQUIREMENTS
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7/12/2013
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22-B10632
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POST-APPROVAL REQUIREMENTS AND REPORTS
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7/12/2013
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22-B10699
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DEFINITIONS
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7/12/2013
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