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 FDA Form 356h PROPOSED FDA Form 356h for ICR 0338.pdf Supplementary Document 05/23/2017 0338 Non Substantive Change Request 0338 Non sub change 2017.pdf Justification for No Material/Nonsubstantive Change 05/23/2017 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received