New York University Hemoblast Bellows Post Market PMA Supplement EssaySchool

New York University

Question Description

The manufacturer is expected to apply post-market phase changes to the product. Assess the following and prepare an appropriate post-market supplement rationale inclusive of PMA type category and high-level overview of rationale to be included in submission. 1) Modified design/components including material change. 2) Change in the controls of the manufacturing environment.