PMA P160001S005

Device: Obalon Balloon Sustem
Applicant: Medtimo, Inc.
PMA number: P160001
Supplement: S005
Product code: LTI
Decision date: 2017-03-09
Classification: Implant, Intragastric For Morbid Obesity
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: Approval for labeling changes have been requested by the Office of Surveillance and Biometrics, Signal Management Program as a result of a safety signal with fluid filled gastric balloons.

Current openFDA PMA Record#

Device: Obalon Balloon Sustem
Applicant: Medtimo, Inc.
PMA number: P160001
Supplement: S005
Product code: LTI
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date: 2017-03-09
Decision code: APPR
Date received: 2017-03-02
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for labeling changes have been requested by the Office of Surveillance and Biometrics, Signal Management Program as a result of a safety signal with fluid filled gastric balloons.