Securing FDA Approval For Novel OPRA Prosthetic Wasn’t A ‘Slam Dunk.’ Here’s How Start-Up Integrum Made It Through The PMA Maze

In this case study, experts at the law firm Hogan Lovells and device maker Integrum AB tell Medtech Insight about some hurdles the Swedish start-up jumped when trying to win premarket approval from the US FDA for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.

Case Study

When medtech industry attorney Jonathan Kahan began working with Swedish start-up Integrum AB to secure premarket approval (PMA) from the US Food and Drug Administration for the company’s novel OPRA prosthetic, he wasn’t sure the agency would ultimately approve the device.

“When we started this project, this was not necessarily a slam dunk,” Kahan, a partner with the law firm Hogan...

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