New York University Hemoblast Bellows Post Market PMA Supplement EssaySchool

New York University Hemoblast Bellows Post Market PMA Supplement EssaySchool

  

New York University Hemoblast Bellows Post Market PMA Supplement EssaySchool

New York University

Question Description

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170012

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.

  
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