Manufacturers of the surgical mesh devices have not provided reasonable assurances of safety and effectiveness, according to the agency.
The companies are finally putting to bed all outstanding patent disputes.
The company continues to drive global expansion by investing in high growth segments and expanding its innovation pipeline to new markets.
The $435-million deal is part of the company’s commitment to being a leader in products for transcatheter aortic valve implantation.
The company is performing well across all business units and geographies.
The addition of Cosman Medical, a manufacturer of radiofrequency ablation systems, enhances the company’s product line for chronic pain.
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The company plans to reinvest savings of the restructuring program into strategic growth initiatives.
Following a safety alert, the agency issued an update about possible counterfeit raw materials in urogynecologic mesh implants.
The goal is to deliver new technologies to doctors faster.