PMA
P190012: Spatz3 Adjustable Balloon System
FDA PMA · IMPLANT, INTRAGASTRIC FOR MORBID OBESITY · Spatz Fgia, Inc.
Key facts
| PMA number | P190012 |
|---|---|
| Trade name | Spatz3 Adjustable Balloon System |
| Generic name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
| Applicant | Spatz Fgia, Inc. |
| Owner/operator | Spatz FGIA Inc. |
| Product code | LTI |
| Approval date | Oct 15, 2021 |
| Establishment registration | 3020798856 |
| FEI number | 3020798856 |
At a glance
- 1–9 Supplements
- Feb 29, 2024 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: