Angiotech Pharmaceuticals (ANPI) Receives FDA Letter Regarding 510k Submission of Bio-Seal
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Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI) 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 (PMA) 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.
Should Angiotech elect to continue to pursue development or regulatory approvals for this product candidate that require the company to incur material expense, Angiotech will provide further updates in its public disclosure. Angiotech has not incurred material expense to date with respect to activities regarding this product candidate.
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