This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Spatz3 Adjustable Balloon System |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | Spatz FGIA Inc.1801 S Perimeter Rdsuite 130ft. Lauderdale, FL 33309 PMA NumberP190012 Supplement NumberS003 Date Received01/05/2023 Decision Date01/23/2023 Product Code LTI Advisory Committee Gastroenterology/Urology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2023-01-05 |
| Decision Date | 2023-01-23 |
| PMA | P190012 |
| Supplement | S003 |
| Product Code | LTI |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Spatz FGIA Inc. 1801 S Perimeter Rd suite 130 ft. Lauderdale, FL 33309 PMA NumberP190012 Supplement NumberS003 Date Received01/05/2023 Decision Date01/23/2023 Product Code LTI Advisory Committee Gastroenterology/Urology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo 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. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190012 | Original Filing | |
| S003 | 2023-01-05 | Special (immediate Track) |
| S002 | ||
| S001 |