The FDA has cleared Boston Scientific's Promus Element Plus chromium heart stent, according to a Wall Street Journal report.
The company expects the approval will add $200 million to annualized gross margin in the United States and Japan by the end of 2012.
The early approval might allow the company to record a pretax charge of $40 million during the fourth quarter of this year.
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The company expects the approval will add $200 million to annualized gross margin in the United States and Japan by the end of 2012.
The early approval might allow the company to record a pretax charge of $40 million during the fourth quarter of this year.
Related Articles on Medical Device Approvals:
FDA Clears Aptus Endosystems EndoStapling System
FDA Approves Carestream's Vue Motion Medical Image Viewer
FDA Approval for Edwards' Sapien Device is a First for U.S. Market