PMA
P980044: SUPARTZ FX
FDA PMA · Acid, hyaluronic, intraarticular · Seikagaku Corp.
Key facts
| PMA number | P980044 |
|---|---|
| Trade name | SUPARTZ FX |
| Generic name | Acid, hyaluronic, intraarticular |
| Applicant | Seikagaku Corp. |
| Owner/operator | SEIKAGAKU CORPORATION |
| Product code | MOZ |
| Approval date | Jan 24, 2001 |
| Docket number | 01M-0342 |
| Notice date | Aug 13, 2001 |
| Establishment registration | 9612392 |
| FEI number | 1000255210 |
At a glance
- 10–99 Supplements
- Sep 4, 2026 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- No Withdrawn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: