ICR Documents

Supporting Statement A Document Date Uploaded 0078 IDEs SSA 2022 Rev ver 2.docx 02/07/2023 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