2005P-0121:
Non-invasive Bone Growth Stimulator be reclasssified from Class
III to Class II in accordance with Secton 513(e) of the Food and
Drug and Cosmetic Act(FDCA), 21 CFR 860.123 and 21 CFR 860.130
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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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| CCP1
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| 03/29/2005
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| 02/09/2005
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| Device Industry
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| RS Medical
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| Table
of Contents
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| Signature:
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| William Carroll
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| ACK1
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| 03/30/2005
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| 03/30/2005
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| Federal Government
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| HFA-305 to RS Medical
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| pdf
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| Signature:
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| Lyle D. Jaffe
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| C1
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| 07/01/2005
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| 06/28/2005
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| Academial
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| Upstate Medical University
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| pdf
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| Signature:
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| Hansen A. Yuan, M.D.
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| C2
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| 07/11/2005
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| 07/08/2005
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| Drug Industry
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| EBI A Biomet Company
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| pdf
Att 1,
Att 2
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| Links updated 4/27/07
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| Signature:
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| Barry E. Sands
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| TS1
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| 07/21/2005
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| 07/21/2005
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| Private Industry
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| King & Spalding
LLP
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| pdf
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| Signature:
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| Edward M Basile
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| C3
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| 07/27/2005
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| 07/26/2005
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| Academia
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| Robert Wood Johnson
Medical School
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| pdf
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| Signature:
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| Nicola C. Partridge, PhD
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| LET1
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| 08/03/2005
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| 08/03/2005
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| Federal Government
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| HFZ-1 to RS Medical
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| pdf
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| Signature:
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| Linda S Kahan
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| LET2
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| 08/04/2005
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| 08/04/2005
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| Device Industry
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| RS Medical
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| pdf
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| Signature:
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| William Carroll
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| LET3
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| 08/18/2005
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| 08/18/2005
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| Federal Government
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| HFZ-400 to RS Medical
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| pdf
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| Signature:
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| Donna-Bea Tillman, PhD
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| C4
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| 08/17/2005
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| 08/17/2005
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| Private Industry
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| BGS Reclassification
Opposition Group (BGS Group)
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| Table
of Contents
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| Signature:
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| Edward M. Basile
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| C5
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| 08/18/2005
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| 08/12/2005
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| Private Industry
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| Texas Back Institute
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| pdf
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| Signature:
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| Barton L. Sachs, MD, MBA
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| C6
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| 10/11/2005
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| 10/11/2005
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| Private Industry
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| DJ Ortho
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| pdf,
Tab A, Tab
B
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| Signature:
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| Donald M Roberts
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| C7
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| 10/11/2005
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| 10/11/2005
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| Private Industry
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| Core Medical Center
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| pdf
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| Signature:
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| Raymond J Linovitz MD FACS
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| SUP1
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| 10/13/2005
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| 10/13/2005
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| Private Industry
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| DJ Ortho
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| pdf
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| Supplement material
to C6
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| Signature:
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| DJ Ortho
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| C8
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| 10/12/2005
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| 10/12/2005
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| Private Industry
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| Foundren Orthopedic
Group, LLC
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| pdf
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| Signature:
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| John O. Bishop, MD
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| AMD1
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| 12/06/2005
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| 12/06/2005
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| Device Industry
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| RS Medical
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| Table
of Contents
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|
|
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| Signature:
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| William Carroll
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| C9
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| 02/10/2006
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| 02/10/2006
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| Private Industry
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| BGS Reclassification
Opposition Group (BGS Group)
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| pdf
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|
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| Signature:
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| Edward M. Basile
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| C10
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| 02/17/2006
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| 02/17/2006
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| Private Industry
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| EBI., L.P.
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| pdf
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| Signature:
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| Jonathan S. Kahan
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| C11
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| 03/07/2006
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| 03/07/2006
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| Private Industry
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| BGS Reclassification
Opposition Group (BGS Group)
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| pdf
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|
|
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| Signature:
| Edward M. Basile
| |
|
| TS2
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| 04/10/2006
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| 04/10/2006
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| Private Industry
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| King & Spalding
LLP
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|
|
|
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|
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| pdf
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| Opposition to the
Down-Classification of External Bone Growth Stimulators
|
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| Signature:
| Edward M. Basile
| |
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| RC1
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| 05/02/2006
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| 05/01/2006
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| Device Industry
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| RS Medical
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| pdf
Attachment
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|
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| Signature:
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| Robert L. Sheridan
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| SUP2
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| 05/18/2006
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| 05/18/2006
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| Device Industry
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| RS Medical
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| pdf
Attachments
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|
|
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| Signature:
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| Natalia Owen, M.S., CCRA
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|
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| LET4
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| 05/19/2006
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| 05/19/2006
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| Device Industry
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| BGS Reclassification
Opposition Group (BGS Group)
|
|
|
|
|
|
|
| pdf
Attachment
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|
|
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| Signature:
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| Edward M. Basile
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|
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| C12
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| 05/19/2006
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| 05/19/2006
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| Academia
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| Columbia University
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| pdf
Attachment
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|
|
|
| Signature:
|
| Arthur A. Pilla, PhD
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|
|
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| N1
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|
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| 01/16/2007
|
| FDA
|
| FDA
|
| 01/17/2007
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| 1951-1954
|
| 04/17/2007
|
| txt
|
| Comment due on 04/17/2007
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|
| Signature:
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| KAHAN, S. LINDA
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|
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| BKG1
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| 01/12/2007
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| 03/30/2005
|
| Federal Government
|
| Background Material
|
|
|
|
|
|
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|
|
| 2 Total Volumes
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|
|
|
| Signature:
|
| Background Material
|
|
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| C13
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| 03/09/2007
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| 03/07/2007
|
| Private Industry
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| Pennsylvania Spine
Institute
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| William J Beutler MD
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|
|
| C14
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| 03/27/2007
|
| 03/18/2007
|
| Private Industry
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| The Cleveland Clinic
Foundation
|
|
|
|
|
|
|
| pdf
Attachments
|
|
|
|
| Signature:
|
| Ronald J Midura PhD
|
|
|
| WDL1
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| 04/05/2007
|
| 04/02/2007
|
| Device Industry
|
| RS Medical
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| William Carroll
|
|
|
| C15
|
| 04/10/2007
|
| 04/05/2007
|
| Private Industry
|
| Shapiro Clinical Center
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Paul A Glazer MD
|
|
|
| C16
|
| 04/16/2007
|
| 04/11/2007
|
| Private Industry
|
| Center for Orthopaedics
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Neil Kahanovitz, M. D.
|
|
|
|
| C17
|
| 04/17/2007
|
| 04/12/2007
|
| Private Industry
|
| Healthonics-The Biophysics
Health Company
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Jim Naftel
| |
|
|
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| C18
|
| 04/17/2007
|
| 04/16/2007
|
| Private Industry
|
| Smith & Nephew
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Barbara Rohan
|
|
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| C19
|
| 04/17/2007
|
| 04/17/2007
|
| Private Industry
|
| Bone Growth Stimulator
(BGS)
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Edward M. Basile
| |
|
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Top
| Up
Page last updated:
April 27, 2007
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