Johnson & Johnson wins FDA De Novo clearance for OTTAVA robotic surgery system in US
JNJ•FDA clears OTTAVA for U.S. use
Johnson & Johnson said the FDA granted De Novo market authorization for its OTTAVA robotic surgical system in the U.S.
Initial procedures and launch plans
The system was cleared for multiple upper-abdominal general surgery procedures, including bariatric surgery, gallbladder removal, and appendectomy.
The company plans a limited U.S. commercial launch with select customers while pursuing additional indications.
