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ORBERA Intragastric Balloon System

by Boston Scientific

PMA P140008

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P140008↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP140008 Date5 Aug 2015ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
ORBERA® Intragastric Balloon (IGB) System
Trade name
Orbera Intragastric Balloon
Generic name
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
FDA applicant
Boston Scientific Corporation
PMA number
FDA product code
LTI
Device class
Class III
Advisory committee
Gastroenterology, Urology
FDA decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ORBERA Intragastric Balloon System is an implant indicated for use as an adjunct to weight reduction for adults with obesity having a body mass index (BMI) of 30 to 40 kg/m². It is designed to be used in conjunction with a long-term supervised diet and behavior modification program to increase the possibility of significant long-term weight loss and maintenance.

The system is supplied for placement via endoscopic procedure and is intended for a maximum placement period of 6 months. It is a single-use implant regulated under FDA PMA (P140008) and is not indicated for MRI safety or reuse; storage and handling specifications are not provided in the source data.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the maximum placement period for the ORBERA Intragastric Balloon System?

    The maximum placement period for the ORBERA Intragastric Balloon System is 6 months, as stated in the approval documentation, which specifies that the device is not intended for longer-term implantation.

  • Who manufactures the ORBERA Intragastric Balloon System?

    The ORBERA Intragastric Balloon System is manufactured by Boston Scientific Corporation, as indicated in the applicant and manufacturer fields of the device data.

  • Is the ORBERA Intragastric Balloon System indicated for patients with a BMI below 30?

    No, the ORBERA Intragastric Balloon System is indicated only for adults with a body mass index (BMI) of 30 to 40 kg/m²; use in patients with BMI below 30 is not supported by the approved labeling.