ICR Documents

Document Date Uploaded
Health_Care_response_to_Medical_Device_Labeling_SS_Part_A.docx 07/03/2012

Document Date Uploaded
Health_Care_response_to_Medical_Device_Labelin_SS_Part_B.docx 07/02/2012

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

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