ORBERA Intragastric Balloon

FDA premarket approval P140008/S013 · decided 2018-08-17

Approval details

PMA number

P140008

Supplement

S013

Supplement type

Normal 180 Day Track No User Fee

Supplement reason

Postapproval Study Protocol

Trade name

ORBERA Intragastric Balloon

Generic name

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Applicant

Boston Scientific Corporation

Date received

2018-06-12

Decision date

2018-08-17

Days to decision

66 days

Decision code

APPR

Product code

LTI

Advisory committee

Gastroenterology, Urology

Expedited review

No

Location

Marlboro, MA

Statement

Approval for the ORBERA Intragastric Balloon System. The device is indicated for use as an adjunct to weight reduction for adults with obesity with Body Mass Index (BMI) of >= 30 and <= 40 kg/m2 and is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of significant long-term weight loss and maintenance of that weight loss. ORBERA is indicated for adult patients who have failed more conservative weight reduction alte

510(k) clearances by this applicant