FzioMed Inc. (Hogan Lovells US LLP) - Citizen Petition
This Other document was issued by the Food and Drug Administration (FDA)
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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...
Attachment 4 Request for Internal Agency Supervisory Review
Attachment 6 Follow Up Letter Regarding FDA Appeal Meeting Submitted to CDRH on April 25 2012
Appendix A Requested Line Item Data and MS Excel Data Spreadsheets for Confirmatory Studies 1 And 2
Appendix D Spine Article Published Results of Confirmatory Study 2
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Date Posted: Nov 21, 2012
Country: United States
Submitter's Representative: Hogan Lovells US LLP
Category: Private Industry - C0003
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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