FzioMed Inc. (Hogan Lovells US LLP) - Citizen Petition

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FzioMed Inc Hogan Lovells US LLP Citizen Petition

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Authors: cdrh
 

List of Attachments to Petition for Reconsideration

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Attachment 1 Timeline Of Key Regulatory Correspondence

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Attachment 2 Rhyne Al Blumenthal Sl Frank Eh Et Al 2012 Oxiplex Reduces Leg Pain Back Pain and Associated Symptoms After Lumbar...

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Attachment 3 Bibliography

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Attachment 4 Request for Internal Agency Supervisory Review

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Appendix A September 15 2008 Not Approvable Letter

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Appendix B July 27 2009 Response to Not Approvable Letter

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Appendix C January 12 2010 Not Approvable Letter

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Appendix D Minutes From December 6 Meeting Between Fziomed and FDA

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Appendix E Selected References

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Appendix F Timeline of Key Regulatory Correspondence

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Attachment 5 Minutes of April 11 2012 Meeting With FDA

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Attachment 6 Follow Up Letter Regarding FDA Appeal Meeting Submitted to CDRH on April 25 2012

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Attachment 7 Additional Information Response

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Appendix A Requested Line Item Data and MS Excel Data Spreadsheets for Confirmatory Studies 1 And 2

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Appendix B Data Dictionary

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Appendix C Legend to SAS Programs Used in the Analysis

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Appendix D Spine Article Published Results of Confirmatory Study 2

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Appendix E Statistical Analysis Plan

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Attachment 8 Letter From CDRH Upholding the not Approvable Decision October 9 2012

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ID: FDA-2012-P-1107-0001

Document Information

Date Posted: Nov 21, 2012
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Submitter Information

Country: United States
Submitter's Representative: Hogan Lovells US LLP
Category: Private Industry - C0003

Comments

25
Comments Received*
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A small but significant number of patients continue to suffer from low back and/or leg pain following appropriate lumbar decompression. In these patients, the...
We regularly apply Medishield after lumbar disc surgeries to prevent scarring after revision surgery. We have truuly very good outcomes in our patients with...

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