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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
|
| Files
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| Remarks
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|
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| NM1
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|
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| 09/29/2005
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| FDA
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| FDA
|
| 10/04/2005
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| 57881-57883
|
|
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| pdf
|
| Meeting on 11/17/05
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|
| Signature:
|
| Jeffrey Shuren
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|
|
| APE1
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| 10/12/2005
|
| 10/12/2005
|
| Device Association
|
| Association
of Medical Device Reprocessors (AMDR)
|
|
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|
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|
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| Signature:
|
| Naomi Joy Levan Halpern
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|
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| TR1
|
| 12/14/2005
|
| 12/14/2005
|
| Federal
Government
|
| Transcript of November
17, 2005 Meeting
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|
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|
| txt,
01, 02
|
|
|
|
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|
| LST1
|
| 12/15/2005
|
| 12/15/2005
|
| Federal
Government
|
| Agenda for
November 17, 2005 Stakeholder Meeting
|
|
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|
|
|
|
| doc
|
|
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| TS1
|
| 12/15/2005
|
| 12/15/2005
|
| Device Association
|
| Medical
Device Manufacturers Association (MDMA)
|
|
|
|
|
|
|
| pdf,
ppt
|
| The User Fee Structure
|
|
| Signature:
|
| Mark Leahey
|
|
|
| TS2
|
| 12/15/2005
|
| 12/15/2005
|
| Association
|
| Advanced
Medical Technology (AdvaMed), Cordis Corporation
|
|
|
|
|
|
|
| pdf,
ppt
|
| MDUFMA Stakeholders
Meeting - Performance Goals
|
|
| Signature:
|
| Marlene Valenti
|
|
|
| TS3
|
| 12/15/2005
|
| 12/15/2005
|
| Device Association
|
| National Electrical
Manufacturers Association
|
|
|
|
|
|
|
| pdf,
ppt
|
| Performance Goals
|
|
| Signature:
|
| Robert Britain
|
|
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| TS4
|
| 12/15/2005
|
| 12/15/2005
|
| Association
|
| Advanced Medical Technology
(AdvaMed)
|
|
|
|
|
|
|
| pdf,
ppt
|
| Qualitative Performance
Goals
|
|
| Signature:
|
| Patricia B Shrader
|
|
|
| TS5
|
| 12/15/2005
|
| 12/15/2005
|
| Association
|
| National Electrical
Manufacturers Association
|
|
|
|
|
|
|
| pdf,
ppt
|
|
|
|
| Signature:
|
| Robert Britain
|
|
|
| TS6
|
| 12/15/2005
|
| 12/15/2005
|
| Association
|
| Advanced
Medical Technology Association (AdvaMed)
|
|
|
|
|
|
|
| pdf,
ppt
|
|
|
|
| Signature:
|
| Diane Wurzburger
|
|
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| TS7
|
| 12/15/2005
|
| 12/15/2005
|
| Device Association
|
| Association of Medical
Device Reprocessors
|
|
|
|
|
|
|
| pdf,
ppt
|
|
|
|
| Signature:
|
| Naomi Halpern
|
|
|
| TS8
|
| 12/15/2005
|
| 12/15/2005
|
| Device Association
|
| Association of Medical
Device Reprocessors
|
|
|
|
|
|
|
| pdf,
ppt
|
| Reprocessing
of Single-Use Devices (SUD's)
|
|
| Signature:
|
| Tony Blank
|
|
|
|
|
| TS9
|
| 12/15/2005
|
| 12/15/2005
|
| Device Association
|
| National Electrical
Manufacturers Association
|
|
|
|
|
|
|
| pdf,
ppt
|
|
|
|
| Signature:
|
| Robert Britain
|
|
|
| TS10
|
| 12/15/2005
|
| 12/15/2005
|
| Device Industry
|
| National Venture Capital
Association (NVCA)
|
|
|
|
|
|
|
| pdf,
ppt
|
|
|
|
| Signature:
|
| Jack Lasersohn
|
|
|
| TS11
|
| 12/15/2005
|
| 12/15/2005
|
| Consumer Group
|
| National Research
Center for Women & Families
|
|
|
|
|
|
|
| pdf,
ppt
|
|
|
|
| Signature:
|
| Diana Zuckerman PhD
| |
|
| NM2
|
|
|
| 04/12/2006
|
| FDA
|
| FDA
|
| 04/13/2006
|
| 19192-19193
|
|
|
| htm
pdf
|
| Meeting on 5/22/06
|
|
| Signature:
|
| JEFFREY SHUREN
|
|
|
| TR2
|
| 06/08/2006
|
| 06/08/2006
|
| Federal Government
|
| Transcript of the May 22, 2006 Meeting
|
|
|
|
|
|
|
| pdf
txt
|
|
|
|
|
|
| TS12
|
| 06/08/2006
|
| 06/08/2006
|
| Federal Government
|
| Barnett Intro for MDUFMA
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Mark Barnett
|
|
|
| TS13
|
| 06/08/2006
|
| 06/08/2006
|
| Federal Government
|
| Linda Kahan Opening Remarks for 05/22/2006 meeting
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Linda Kahan
|
|
|
| LST2
|
| 06/13/2006
|
| 06/13/2006
|
| Federal Government
|
| Agenda for May 22, 2006 Stakeholder Meeting
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| TS14
|
| 06/13/2006
|
| 06/13/2006
|
| Federal Government
|
| CDRH: MDFUMA Performance Update
|
|
|
|
|
|
|
| pdf
ppt
|
|
|
|
|
| Signature:
|
| Donna-Bea Tillman, PhD
|
|
|
| TS15
|
| 06/13/2006
|
| 06/13/2006
|
| Association
|
| National Venture Capital Association
|
|
|
|
|
|
|
| pdf
ppt
|
| FDA Stakeholder Meeting On Implementation of MDUFMA Review Performance Goals
|
|
| Signature:
|
| David Douglass
|
|
|
|
|
|
|
|