PMA
P900052: PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYSTEM
FDA PMA · CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL · Smiths Medical Asd, Inc.
Key facts
| PMA number | P900052 |
|---|---|
| Trade name | PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYSTEM |
| Generic name | CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL |
| Applicant | Smiths Medical Asd, Inc. |
| Owner/operator | Merit Medical Systems, Inc. |
| Product code | LNY |
| Approval date | Apr 22, 1991 |
| Docket number | 91M-0167 |
| Notice date | Jun 7, 1991 |
| Establishment registration | 3012276280 |
| FEI number | 3012276280 |
At a glance
- 10–99 Supplements
- May 13, 2013 Latest supplement decision
- Yes Withdrawn
- No 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: