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Spatz3 Adjustable Balloon System

by Spatz Fgia, Inc.

PMA P190012Ref A-SP3-03K

Active European Union and United States

CE MDD PMA

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

PMA P190012↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00860005178810 Basic UDI-DI 00860005178810UDI-DIDate19 Jan 2022RegisteredStatusActive
United StatesFDA PMAAPPR PMA Approved NumberP190012 Date15 Oct 2021ApprovedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA PMA Active

Specification

EUDAMED · PMA

Generic Name
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Device Name
Spatz3 Adjustable Balloon System Insertion Kit
Model / Reference
A-SP3-03K
Primary DI / UDI-DI
00860005178810
Basic UDI-DI
B-00860005178810
PMA Number
FDA Product Code
LTI
EMDN Code
G030601 Intragastric balloon systems
Device Class
Class IIb EUDAMED
Class III PMA
EU market of registration
Spain
Advisory Committee
Gastroenterology, Urology
FDA Decision
APPR Approved

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDPMA
Device ClassEUDAMED
Class IIb
PMA
Class III

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 Spatz3 Adjustable Balloon System is an intragastric implant designed to assist with weight loss in adults. It is indicated for individuals with a Body Mass Index of 35.0 to 40.0 kg/m2, or those with a BMI of 30.0 to 34.9 kg/m2 who have at least one major obesity-related comorbid condition and have failed to achieve weight loss through supervised programs.

This device is intended for temporary use for a maximum placement period of 8 months. It must be used in conjunction with a long-term supervised diet and behavior modification program to support weight-loss maintenance. The system is authorized under FDA PMA and MDD regulatory frameworks.

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 primary purpose of the Spatz3 Adjustable Balloon System?

    The system is an intragastric implant indicated for temporary weight loss in adults with obesity who have not achieved success with supervised weight control programs.

  • How long can the Spatz3 Adjustable Balloon remain in the body?

    The maximum placement period for the Spatz3 Adjustable Balloon System is 8 months, as it is designed for temporary use.

  • Who is a candidate for this intragastric balloon?

    Candidates include adults with a BMI of 35.0-40.0 kg/m2, or those with a BMI of 30.0 to 34.9 kg/m2 who also have one or more major obesity-related comorbid conditions.

Properties

  • Implantable

Other properties (10)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No