|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
|
|
| NPR1
|
|
|
| 10/30/2006
|
| FDA
|
| FDA
|
| 10/31/2006
|
| 63728-63732
|
| 01/29/2007
|
| txt
|
|
|
|
|
| Signature:
|
| Linda S. Kahan
|
|
|
|
|
| REF1
|
| 10/30/2006
|
| 10/30/2006
|
| Federal Government
|
| Reference
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Reference
|
|
|
|
|
|
|
| REF2
|
| 10/30/2006
|
| 10/30/2006
|
| Federal Government
|
| Reference
|
|
|
|
|
|
|
| pdf
Continued
|
|
|
|
|
|
|
| Signature:
|
| Reference
|
|
|
|
|
| EXT1
|
| 12/13/2006
|
| 12/08/2006
|
| Device Industry
|
| Ferrosan A/S, Sydmarken
5, DK-2860 Soeborg
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Mark E. DuVal
|
|
|
|
|
| EXT2
|
| 12/21/2006
|
| 12/21/2006
|
| Private Industry
|
| Ethicon, Inc.
|
|
|
|
|
|
|
| pdf
Attachment
|
| CF 2006D-0363/EXT1
|
|
|
| Signature:
|
| Jeffrey N. Gibbs
|
|
|
|
|
| EC1
|
| 01/29/2007
|
| 01/28/2007
|
| Academia
|
| Duke University
|
|
|
|
|
|
|
| htm
Attachment
|
|
|
|
|
| Signature:
|
| Lawson, Jeffrey
|
|
|
|
|
| C1
|
| 01/26/2007
|
| 01/26/2007
|
| Academia
|
| Jefferson University
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Cataldo Doria MD, PhD
|
|
|
|
|
| C2
|
| 01/29/2007
|
| 01/25/2007
|
| Device Industry
|
| Ferrosan A/S, Sydmarken
5, DK-2860 Soeborg
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Mark E. DuVal
|
|
|
|
|
| C3
|
| 01/29/2007
|
| 01/29/2007
|
| Academia
|
| Duke University Medical
Center
|
|
|
|
|
|
|
| pdf
Attachment
|
|
|
|
|
| Signature:
|
| Jeffrey H. Lawson, M.D., PhD
|
|
|
|
|
| C4
|
| 01/29/2007
|
| 01/29/2007
|
| Device Industry
|
| Ethicon, Inc. (Ethicon)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Jeffrey N. Gibbs
|
|
|
|
|
| EC2
|
| 01/30/2007
|
| 01/29/2007
|
| Device Industry
|
| Vascular Solutions
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Neymark, Deborah
| |
|
|
|
|
|
| C5
|
| 04/27/2007
|
| 04/27/2007
|
| Private Industry
|
| Orthovita Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Gina M Nagvajara PhD
|
|
|
|
|
| NEC1
|
|
|
| 05/07/2007
|
| FDA
|
| FDA
|
| 05/08/2007
|
| 26011-26011
|
| 06/07/2007
|
| txt
|
|
|
|
|
| Signature:
|
| Jeffrey Shuren
|
|
|
|
|
|
| C6
|
| 05/23/2007
|
| 05/23/2007
|
| Private Industry
|
| North Shore Long Island
Jewish Health System
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| David Zoltsman, M.D.
|
|
|
|
|
| C7
|
| 05/29/2007
|
| 05/29/2007
|
| Private Industry
|
| Center for general
and Minimally Invasive Surgery
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Miguel R Silva MD
|
|
|
|
|
| C8
|
| 05/29/2007
|
| 05/29/2007
|
| Private Industry
|
| Beth Israel Deaconess
Medical Center
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| E Papavassilious MD
|
|
|
|
|
| C9
|
| 05/30/2007
|
| 05/30/2007
|
| Private Industry
|
| Premier
Cardiothoracic and Vascular Surgeons Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
|
| Signature:
|
| B Justin Kim MD
|
|
|
|
|
| C10
|
| 05/30/2007
|
| 05/30/2007
|
| Private Industry
|
| Duke University Medical
Center
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| David M Albala MD
|
|
|
|
|
| C11
|
| 05/31/2007
|
| 05/31/2007
|
| Private Industry
|
| R Adams Cowley Shock
Trauma Center
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Grant V Bochicchio MD MPH FACS
| |
|
|
|
|
|
| C12
|
| 06/01/2007
|
| 06/01/2007
|
| Private Industry
|
| Methodist Hospital
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Craig P Fischer MD MPH FACS
|
|
|
|
|
| C13
|
| 06/05/2007
|
| 05/31/2007
|
| Private Industry
|
| Gropper Neurosurgical
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Gary R. Gropper, M. D.
|
|
|
|
|
| C14
|
| 06/05/2007
|
| 05/31/2007
|
| Private Industry
|
| Capital City Neurosurgical
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Roger H. Frankel, M. D.
|
|
|
|
|
| C15
|
| 06/05/2007
|
| 05/31/2007
|
| Private Industry
|
| Capital City Neurosurgical
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Christopher E. Clare, M. D.
|
|
|
|
|
| C16
|
| 06/04/2007
|
| 05/31/2007
|
| Academia
|
| University of Pennsylvania
Health System
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Bert W. O'Malley, Jr., M. D.
|
|
|
|
|
|
| C17
|
| 06/04/2007
|
| 06/04/2007
|
| Academia
|
| University of Cincinnati
Surgeons, Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Amit D. Tevar, M. D.
|
|
|
|
|
| EC3
|
| 06/07/2007
|
| 06/06/2007
|
| Device Industry
|
| Z-Medica Corporation
|
|
|
|
|
|
|
| htm
|
|
|
|
|
| Signature:
|
| Peterson, Ronald
|
|
|
|
|
| C18
|
| 06/06/2007
|
| 06/05/2007
|
| International Industry
|
| Ferrosan A/S
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Mark E Duval
|
|
|
|
|
| C19
|
| 06/06/2007
|
| 06/06/2007
|
| Private Industry
|
| HemCon Medical Technologies
Inc (HemCon)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Carol A Pratt PhD
|
|
|
|
|
| C20
|
| 06/06/2007
|
| 06/06/2007
|
| Private Industry
|
| Oakwood Hospital &
Medical Cente
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Timothy L Sell MD
|
|
|
|
|
| C21
|
| 06/06/2007
|
| 06/06/2007
|
| Private Industry
|
| Vascular & Transplant
Specialists
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Marc H Glickman MD
|
|
|
|
|
| C22
|
| 06/06/2007
|
| 06/06/2007
|
| Private Industry
|
| HemCon Medical Technologies
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| John W Morgan
|
|
|
|
|
| C23
|
| 06/07/2007
|
| 06/07/2007
|
| Academia
|
| University of California,
Los Angeles
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Timothy L Van Natta MD
|
|
|
|
|
|
| C24
|
| 06/07/2007
|
| 06/07/2007
|
| Private Industry
|
| Carolina NeutroSurgery
& Spine Associates
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Anthony Asher MD
|
|
|
|
|
| C25
|
| 06/07/2007
|
| 06/07/2007
|
| Private Industry
|
| Ethicon Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Jeffrey N Gibbs
|
|
|
|
|
| C26
|
| 06/07/2007
|
| 06/07/2007
|
| Academia
|
| University of Virginia
Health System, Department of Neurological Surgery
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Mark Shaffrey MD
|
|
|
|
|
| C27
|
| 06/08/2007
|
| 06/07/2007
|
| Health Professional
|
| B. Ceverha
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| CP1
|
| 07/06/2007
|
| 07/09/2007
|
| International Industry
|
| Ferrosan A/S
|
|
|
|
|
|
|
| pdf
|
| Citizen petition and
petition of stay of action
|
|
|
|
|
| Signature:
|
| Mark E. DuVal
|
|
|
|
|
|
|
|
| ACK1
|
| 07/09/2007
|
| 07/09/2007
|
| Federal Government
|
| FDA/DDM to DuVal &
Associates
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Lyle D. Jaffe
|
|
|
|
|
|
|
| EC4
|
| 07/30/2007
|
| 07/11/2007
|
| Health
Professional
|
| Miss. Beth
Lamond
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| BKG1
|
| 10/11/2007
|
| 10/11/2007
|
| Federal
Government
|
| FDA/CDRH
|
|
|
|
|
|
|
| Table of Contents
|
|
|
|
|
|
| Signature:
|
| Marjorie Shulman
|
|
|
| |
|
|
|
|
