ICR Documents

Supporting Statement A Document Date Uploaded 0338 Supporting Statement 2016 extension.pdf 01/17/2017 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded Form FDA 356h 0338 Form FDA 356h.pdf Supplementary Document 04/11/2018 0338 Non sub change request 2018 0338 Non sub change 2018.docx Justification for No Material/Nonsubstantive Change 04/09/2018 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received