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TransPyloric Shuttle Delivery Device

by Baronova, Inc.

PMA P180024

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 P180024↗

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 NumberP180024 Date16 Apr 2019ApprovedStatusActive

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  • Withdrawn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
TransPyloric Shuttle/TransPyloric Shuttle Delivery Device
Generic Name
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
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 TransPyloric Shuttle Delivery Device is an Implant, Intragastric for Morbid Obesity, classified as a Class III medical device. It is designed to assist in weight reduction by creating a physical barrier within the stomach, promoting satiety and reducing food intake in adult patients with obesity.

This device is intended for single-use and is implanted via an endoscopic procedure. It is supplied sterile and requires surgical removal after use. Approved under an FDA Premarket Approval (PMA P180024), it is regulated under the LTI product code and is intended for use in conjunction with dietary and behavioral modification programs in qualifying patients.

Other devices from Baronova, Inc.

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 TransPyloric Shuttle Delivery Device used for in clinical practice?

    The TransPyloric Shuttle Delivery Device is designed to assist in weight reduction by creating a physical barrier within the stomach of adult patients with obesity. It is intended for use in patients with a BMI between 35.0–40.0 kg/m² or those with a BMI of 30.0–34.9 kg/m² who have obesity-related comorbid conditions. It is meant to be used alongside a structured diet and behavioral modification program to promote satiety and reduce food intake.

  • Is the TransPyloric Shuttle Delivery Device intended for single-use or reusable applications?

    The device is explicitly designed for **single-use only**. After implantation via an endoscopic procedure, it requires surgical removal post-use, meaning each unit is not meant to be reused on another patient.

  • How is the TransPyloric Shuttle Delivery Device supplied, and what does that imply for handling?

    The device is supplied **sterile**, which means it is pre-packaged and ready for immediate use in a clinical setting without additional sterilization. This ensures safety and reduces contamination risks during the endoscopic implantation procedure.

  • What regulatory pathway was followed for approval of this device, and what does that mean for clinicians?

    The TransPyloric Shuttle Delivery Device was approved under the **FDA Premarket Approval (PMA) process** (PMA P180024), which is the strictest regulatory route for high-risk medical devices like Class III implants. This means it underwent rigorous clinical trials and review to demonstrate safety and effectiveness before approval, giving clinicians confidence in its intended use for weight reduction in qualifying patients.