FDA.reportPublic FDA data

PMA P140008S017

Device
ORBERA Intragastric Balloon System
Applicant
Boston Scientific Corporation
PMA number
P140008
Supplement
S017
Product code
LTI
Decision date
2019-06-03
Classification
Implant, Intragastric For Morbid Obesity
Generic name
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement
Approval for revised labeling to include current post-market surveillance information, clarifications intended to enhance safety, and additional labeling pieces intended to enhance safety.

Current openFDA PMA Record#

Device
ORBERA Intragastric Balloon System
Applicant
Boston Scientific Corporation
PMA number
P140008
Supplement
S017
Product code
LTI
Generic name
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date
2019-06-03
Decision code
APPR
Date received
2019-03-04
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for revised labeling to include current post-market surveillance information, clarifications intended to enhance safety, and additional labeling pieces intended to enhance safety.