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Agenda
Reg Review
ICR
ICR Documents
Supporting Statement A
Document
Date Uploaded
Health_Care_response_to_Medical_Device_Labeling_SS_Part_A.docx
07/03/2012
Supporting Statement B
Document
Date Uploaded
Health_Care_response_to_Medical_Device_Labelin_SS_Part_B.docx
07/02/2012
Supplementary Documents
Title
Document
Document Type
Date Uploaded
Attachment G - Label Version 3
Attachment G - Label Version 3.pdf
Supplementary Document
03/01/2012
Attachment E - Label Version 1
Attachment E - Label Version 1.pdf
Supplementary Document
03/01/2012
Attachment F - Label Version 2
Attachment F - Label Version 2.pdf
Supplementary Document
03/01/2012
Device Label Survey screenshots
Device Label Survey screenshots.doc
Supplementary Document
03/01/2012
Public Comment
Advamed Comment.pdf
Supplementary Document
03/01/2012
Consent Form In Person
Consent Form In Person.doc
Supplementary Document
07/02/2012
FINAL FDA letter
FINAL FDA letter.doc
Supplementary Document
07/02/2012
Initial Contacting Letter
Initial Contacting Letter.doc
Supplementary Document
07/02/2012
Revised_Follow Up Letter
Revised_Follow Up Letter.doc
Supplementary Document
07/02/2012
Public Comments
Author Name
Comment Document
Author Affiliation
Sponsoring Org.
Type
Category
Date of Comment
Date Comment Received
Anonymous
Advamed Public Comment.pdf
Other -- PDF
Simple
07/02/2012
07/02/2012
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.