SPATZ FGIA (ISRAEL) LTD
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Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit
SPATZ FGIA (ISRAEL) LTD
The Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit (A-SP3-015) contains 3 extension tubes with their 3-way stopcocks (P-SP-142), and 3 IFUs
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Spatz3 Adjustable Balloon System insertion kit
SPATZ FGIA (ISRAEL) LTD
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.