FDA.reportPublic FDA data

PMA P140008S006

Device
Orbera Intragastric Balloon System
Applicant
Boston Scientific Corporation
PMA number
P140008
Supplement
S006
Product code
LTI
Decision date
2017-06-06
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
Orbera Intragastric Balloon System
Applicant
Boston Scientific Corporation
PMA number
P140008
Supplement
S006
Product code
LTI
Generic name
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date
2017-06-06
Decision code
APPR
Date received
2017-05-08
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.