ORBERA Intragastric Balloon System

FDA premarket approval P140008/S019 · decided 2020-12-02

Approval details

PMA number

P140008

Supplement

S019

Supplement type

Normal 180 Day Track No User Fee

Supplement reason

Labeling Change - PAS

Trade name

ORBERA Intragastric Balloon System

Generic name

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Applicant

Boston Scientific Corporation

Date received

2020-06-08

Decision date

2020-12-02

Days to decision

177 days

Decision code

APPR

Product code

LTI

Advisory committee

Gastroenterology, Urology

Expedited review

No

Location

Marlboro, MA

Statement

Approval for the ORBERATM PAS (OPAS-001.0. The OPAS-001 is a prospective, open-label, single-arm study to evaluate the safety and effectiveness of ORBERA for weight reduction in obese adults 22 years and older with a BMI of 30-40 kg/m2. This is a 52-week study in which subjects will be treated during the first 26 weeks with ORBERA in conjunction with a behavioral modification program, followed by 26 weeks of behavioral modification program alone.A total of 284 subjects will be enrolled at 10 to

510(k) clearances by this applicant