Garren Gastric Bubble
by American Edwards Laboratories PMA
Active
PMA P840025
Overview
The Garren Gastric Bubble is an Implant, Intragastric for Morbid Obesity, classified as a Class III medical device. Designed as an intragastric device, it is intended for placement within the stomach to induce a sense of fullness and reduce food intake in patients with severe obesity.
This device is supplied as a reusable, non-sterile implant and is regulated under an FDA Premarket Approval (PMA) with PMA number P840025. It is intended for surgical placement by qualified healthcare professionals and requires proper training and sterile techniques during implantation. The device is not intended for MRI use and must be stored according to manufacturer guidelines.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP840025 | Date23 Jan 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
- PMA Supplement
- S003
Other devices from American Edwards Laboratories
Questions
Is the Garren Gastric Bubble intended for single-use or can it be reused after implantation?
The Garren Gastric Bubble is designed as a **reusable** implant, meaning it is intended to remain permanently within the patient’s stomach after surgical placement. It is not meant for repeated use in different patients, nor is it supplied sterile, as it is meant to be implanted under sterile conditions by a healthcare professional.
What special considerations should be taken into account when storing the Garren Gastric Bubble before implantation?
The device must be stored according to the manufacturer’s guidelines, though specific storage instructions are not detailed in the provided data. Since it is **non-sterile** and intended for surgical implantation, it should be handled in a clean environment and prepared under sterile conditions by qualified personnel prior to use. Additionally, it is not intended for MRI use, so storage near MRI equipment is not recommended.
What regulatory pathway was followed for the approval of the Garren Gastric Bubble, and how can I verify its status?
The Garren Gastric Bubble was approved through the **FDA Premarket Approval (PMA) process**, with PMA number **P840025**. This classification is required for Class III devices, which include those intended for life-sustaining or life-supporting uses or those posing potential unreasonable risk of illness or injury. The approval was granted on **January 23, 1986**, following review by the FDA’s Gastroenterology and Urology advisory committee. For verification, you may reference the PMA number or check the FDA’s openFDA database using the listed registration numbers.
Who is responsible for the implantation of the Garren Gastric Bubble, and what qualifications should the surgeon have?
The Garren Gastric Bubble is intended for **surgical placement by qualified healthcare professionals**, specifically surgeons with expertise in intragastric procedures. While the data does not specify exact qualifications, the device’s complexity and intended use for **morbid obesity** suggest that the surgeon should have experience in bariatric or gastrointestinal surgery. Proper training and adherence to sterile techniques during implantation are critical, as the device is not supplied sterile.