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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
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| Files
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| Remarks
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| NM1
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| 09/27/2004
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| FDA
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| FDA
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| 09/28/2004
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| 57940-57941
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| pdf
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| meeting 11/18/04
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| Signature:
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| SHUREN, JEFFREY
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| C1
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| 10/22/2004
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| 10/21/2004
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| Private Industry
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| Command Trust Network,
Inc.
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| pdf
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| Signature:
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| Sybil N. Goldrich
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| TR1
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| 12/16/2004
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| 12/16/2004
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| Federal
Government
|
| Transcript
of November 18, 2004 Stakeholder Meeting
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| txt
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| Signature:
|
| Transcript of November
18, 2004 Stak
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| LST1
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| 12/16/2004
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| 12/16/2004
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| Federal
Government
|
| Agenda for November
18, 2004 meeting
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| htm
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| Signature:
|
| Agenda for November
18, 2004 meet
|
|
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| TS1
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| 12/16/2004
|
| 12/16/2004
|
| Federal
Government
|
| FDA - Financial Aspects
of MDUFMA
|
|
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| htm,
ppt
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| Signature:
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| Frank Claunts
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| TS2
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| 12/16/2004
|
| 12/16/2004
|
| Device Association
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| Advanced
Medical Technology Association (AdvaMed)
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| htm,
ppt
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| User Fee Process
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| Signature:
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| Janet Trunzo
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| TS3
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| 12/16/2004
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| 12/16/2004
|
| Association
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| Medical
Device Manufacturers Association (MDMA)
|
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|
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|
|
| htm,
ppt
|
| How is the
User Processing Fee Working?
|
|
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| Signature:
|
| Mark Leahey
|
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| TS4
|
| 12/16/2004
|
| 12/16/2004
|
| Federal
Government
|
| FDA - Premarket Review
Performance Goals
|
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| htm,
ppt
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| Signature:
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| Donna-Bea Tillman,
Don St. Pierre
|
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| TS5
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| 12/16/2004
|
| 12/16/2004
|
| Federal
Government
|
| FDA - CBER MDUFMA
Activity
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| htm,
ppt
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| Signature:
|
| Leonard Wilson
|
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| TS6
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| 12/16/2004
|
| 12/16/2004
|
| Association
|
| Advanced
Medical Technology Association (AdvaMed)
|
|
|
|
|
|
|
| htm,
ppt
|
| Premarket
Review Performance Goals
|
|
|
|
|
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|
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|
|
|
| Signature:
|
| Patricia B. Shader
|
|
|
| TS7
|
| 12/16/2004
|
| 12/16/2004
|
| Device Association
|
| Advanced
Medical Technology Association (AdvaMed)
|
|
|
|
|
|
|
| htm,
ppt
|
| Premarket
Review Performance Goals
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Mark Leahey
|
|
|
| TS8
|
| 12/16/2004
|
| 12/16/2004
|
| Federal
Government
|
| FDA-CDRH
- MDUFMA and the GMP Inspection Program
|
|
|
|
|
|
|
| htm,
ppt
|
|
|
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|
|
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|
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|
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| Signature:
|
| Tim Ulatowski
|
|
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| TS9
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| 12/16/2004
|
| 12/16/2004
|
| Federal
Government
|
| FDA-CDRH - BIMO and
MDUFMA
|
|
|
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|
|
| htm,
ppt
|
|
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|
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| Signature:
|
| Michael Marcarelli
PharmD
|
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| TS10
|
| 12/16/2004
|
| 12/16/2004
|
| Federal
Government
|
| FDA-CDRH - Modular
PMA Updates
|
|
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|
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|
|
| htm,
ppt
|
|
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|
|
|
| Signature:
|
| Thinh Nguyen
|
|
|
|
|
|
|
|
| TS11
|
| 12/16/2004
|
| 12/16/2004
|
| Federal
Government
|
| FDA-CBER
- CBER and MDUFMA Quantitative Goals
|
|
|
|
|
|
|
| htm,
ppt
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Mary Elizabeth Jacobs,
PhD
|
|
|
| TS12
|
| 12/16/2004
|
| 12/16/2004
|
| Federal
Government
|
| FDA-CDRH-
Inspection by Accredited persons (AP) Program
|
|
|
|
|
|
|
| htm,
ppt
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Jan Welch
|
|
|
| TS13
|
| 12/16/2004
|
| 12/16/2004
|
| Device Association
|
| Advanced
Medical Technology (AdvaMed) and National Electrical Manufacturers
Association (NEMA)
|
|
|
|
|
|
|
| htm,
ppt
|
| Third Party Inspection
Program
|
|
|
|
|
|
| |
|
| Signature:
|
| Diane Wurzburger
| |
