The PMA follows a back-and-forth with the federal watchdog agency over the device that dates back to the initial PMA submission for the Sedasys system in 2008. Ethicon Endo-Surgery got another shot with the FDA after its original PMA bid was denied.
The Cincinnati, Ohio-based business touted data from a study backing the PMA application demonstrating that Sedasys reduces the risk of oversedation and improves recovery rates and overall patient satisfaction.
The PMA covers the Sedasys system for colonoscopy and duodenoscopy procedures.
"The technology will empower health care facilities to more effectively use their limited resources to deliver greater value," said Dr. Daniel Pambianco, medical director of the study and a paid consultant for Ethicon Endo-Surgery, according to a statement.
The FDA re-opened the Sedasys PMA in 2011. The federal watchdog agency also recently gave Ethicon the green-light for a surgical assist device.