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Agenda
Reg Review
ICR
ICR Documents
Supporting Statement A
Document
Date Uploaded
0078_Supporting Statement_2019.doc
10/04/2019
Supporting Statement B
Document
Date Uploaded
Supplementary Documents
Title
Document
Document Type
Date Uploaded
Investigational Device Exemptions Reports and Records
0078--change request--moving OUS to 0078--05-06-21.pdf
Justification for No Material/Nonsubstantive Change
05/14/2021
Revised Change Request 0078
0078 Change Request to include 0741 MAY 2021.docx
Justification for No Material/Nonsubstantive Change
05/24/2021
Public Comments
Author Name
Comment Document
Author Affiliation
Sponsoring Org.
Type
Category
Date of Comment
Date Comment Received
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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The .gov means it's official.
The site is secure.
