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See Latest ArticlesAngiotech Pharmaceuticals Provides Update on Bio-Seal™ 510(K) Submission
Angiotech Pharmaceuticals, 10/20/09
Angiotech Pharmaceuticals, Inc. announced that it has received correspondence from the FDA regarding its 510(k) submission for Bio–Seal, stating that Bio–Seal is a class III device that requires Pre–Market Approval for FDA marketing clearance. As a result, Angiotech is reviewing its options with respect to this product candidate, including possibly appealing this FDA decision, and is discussing the possible preparation of a PMA submission with its partner, Biopsy Sciences, LLC.
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