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Device | Spatz3 Adjustable Balloon System |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | Spatz FGIA Inc. 1801 S Perimeter Rd Suite 130 Ft. Lauderdale, FL 33309 |
PMA Number | P190012 |
Date Received | 04/23/2019 |
Decision Date | 10/15/2021 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT02812160
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Spatz3 Adjustable Balloon System is indicated for temporary use for weight loss in adults with obesity Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The Spatz3 Adjustable Balloon System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight-loss maintenance. The maximum placement period for Spatz3 Adjustable Balloon System is 8 months. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S002 S003 S004 |