EBR Gets Form 483 at New WiSE Manufacturing Site

EBR Systems says FDA issued a Form 483 with two observations following an inspection of the company’s new manufacturing facility in Santa Clara, CA. The inspection is related to the agency’s review of a PMA supplement seeking to add the site as a manufacturing facility for its WiSE cardiac pacing system. EBR describes the observations as routine and said the investigator recorded the company’s response to both observations as “Promised to Correct.”

A 9/28 company update did not disclose details of the observations. EBR said it continues to expect FDA approval of the new manufacturing site by the end of the year.

The company says it installed new manufacturing equipment at the facility as it moves some manual production processes toward automated assembly for the wireless cardiac pacing technology for heart failure patients.