2016 PMA Supplements

A sortable and searchable table of PMA supplements approved by FDA in calendar year 2016, updated monthly. Thirty-day notices excluded. Latest update: approvals through May 31.

FDA approved 74 non-panel-track PMA supplements in May, making for a total of 372 such approvals in the first five months of 2016, up from 308 during the first five months of last year.

Supplements approved in May include labeling expansion of Roche Molecular Systems' Cobas Ampliprep/Cobas Taqman cytomegalovirus test for use with hematopoietic stem-cell transplant patients and to increase the whole blood stability...

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