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3M preparing for lung sealant panel review

This article was originally published in The Gray Sheet

Executive Summary

FDA's General & Plastic Surgery Devices Panel will convene May 12 to review 3M's in situ polymerizable material for sealing air leaks following pulmonary surgery. In May 2000, FDA approved an expedited PMA for Genzyme's FocalSeal-L surgical sealant for a similar indication, following a unanimous approval recommendation by the panel (1"The Gray Sheet" June 5, 2000, p. 15). [To learn about how to 2watch a webcast of the meeting, go to FDAAdvisoryCommittee.com]...

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