3M panel cancelled
This article was originally published in The Gray Sheet
Executive Summary
Lung sealant's previously planned May 12 review by FDA's General & Plastic Surgery Devices Panel is cancelled "by mutual agreement between FDA and the sponsor," according to the agency. 3M characterizes the move as a business decision; the in situ polymerizable sealant remains likely to require panel review at a later date. Results from a five-center, prospective, randomized trial suggesting reduced hospital stays with the sealant are scheduled for May publication in the Annals of Thoracic Surgery (1"The Gray Sheet" April 26, 2004, p. 14)...
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