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.
| Device | Spatz3 Adjustable Balloon System |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | Spatz FGIA Inc. |
| Date Received | 2019-04-23 |
| Decision Date | 2021-10-15 |
| PMA | P190012 |
| Supplement | S |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Spatz FGIA Inc. 15 Cuttermill Rd, #147 great Neck, NY 11021 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190012 | Original Filing | |
| S003 | 2023-01-05 | Special (immediate Track) |
| S002 | ||
| S001 |