PMA
P980017: PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20
FDA PMA · Possis Medical, Inc.
Key facts
| PMA number | P980017 |
|---|---|
| Trade name | PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20 |
| Applicant | Possis Medical, Inc. |
| Approval date | Sep 25, 1998 |
| Docket number | 98M-0835 |
At a glance
- 1–9 Supplements
- Mar 24, 1999 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: