Orbera Intragastric Balloon System Apollo Endosurgery

Please confirm or provide the model lot serial and or catalog number s of the device listed in the medical device report as applicable.

Orbera intragastric balloon system apollo endosurgery.

Important orbera intragastric balloon system safety information. The device listed in this medical device report is an orbera intragastric balloon catalog number b 50000. Apollo endosurgery grf 00345 00r07 6. The current international orbera intragastric balloon system directions for use dfu addresses the known and anticipated potential events of death nausea vomiting and cardiac complications as follows.

To receive orbera you must be willing to also. Table of contents 2. The orbera balloon is a single use device therefore the device is no longer in use. About the orbera.

Apollo endosurgery grf 00346 00r07 page 2 of 31. Before using product read the following information thoroughly. The patient continued to get sicker with nausea fatigue dizziness. The patient was discharged and prescribed xarel.

The orbera intragastric balloon system is a weight loss aid for adults suffering from obesity who have tried other weight loss programs such as following supervised diet exercise and behavior modification programs but who were unable to lose weight and keep it off. A patient with the orbera intragastric balloon had a pulmonary embolism thirteen days post placement and spent four days in the icu. Apollo s products are offered in over 75 countries today and include the overstitch endoscopic suturing system the overstitch sx endoscopic suturing system and the orbera intragastric balloon. The risk of balloon deflation and intestinal obstruction and therefore possible death related to intestinal.

Apollo endosurgery grf 00346 00r07 page 1 of 31 orbera intragastric balloon system orbera directions for use dfu rx only apollo endosurgery inc. Orbera intragastric balloon system. What to expect procedures for orbera. The orbera intragastric balloon system is a weight loss aid for adults suffering from obesity with a body mass index bmi 30 and 40 kg m 2 who have tried other weight loss programs such as following supervised diet exercise and behavior modification programs but who were unable to lose weight and keep it off.

The orbera intragastric balloon system is manufactured by apollo endosurgery and the reshape integrated dual balloon system previously manufactured by reshape medical inc was acquired by apollo. For more information regarding apollo endosurgery go to.