Manufacturers Mentor and Sientra did not adequately comply with post-approval study requirements that look at the long-term safety and risks of silicone implants.
The center will start phasing in efficiencies on March 18.
The strategic acquisitions expand the company’s structural heart disease technologies.
The resignation will be effective in about a month, according to reports.
The new pump allows patients to customize their diabetes management.
The deal will help J&J speed up its entry into the robotics market.
The deal will help strengthen the Edwards portfolio of smart monitoring technologies.
The agency’s intent is to decrease regulatory burden while promoting patient access to products.
The device approvals address critical patient need.
The device has been exhibiting a lockup condition during patient use, leading to potential serious injury or death.