PMA P140008S024

Device: ORBERA ® Intragastric Balloon (IGB) System
Applicant: Boston Scientific Corporation
PMA number: P140008
Supplement: S024
Product code: LTI
Decision date: 2022-10-05
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: Approval for a change to the physician labeling to update Table 21: ORBERA device- and procedure- related adverse events and complaints reported through clinical product surveillance.

Current openFDA PMA Record#

Device: ORBERA ® Intragastric Balloon (IGB) System
Applicant: Boston Scientific Corporation
PMA number: P140008
Supplement: S024
Product code: LTI
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date: 2022-10-05
Decision code: APPR
Date received: 2022-07-11
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a change to the physician labeling to update Table 21: ORBERA device- and procedure- related adverse events and complaints reported through clinical product surveillance.