ICR Documents

Supporting Statement A Document Date Uploaded postmarket AE reporting ss 6-18-09 to OMB.doc 06/18/2009 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded MedWatch Form FDA 3500 reporting 3500.pdf Supplementary Document 02/27/2009 FOR M FD A 35 00A (10/05 ) Reporting 3500A.pdf Supplementary Document 03/27/2009 Reporting Guidance reporting guidanceDOCUMENT.doc Supplementary Document 03/30/2009 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received