PMA
P890055: MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM
FDA PMA · Pump, infusion, implanted, programmable · Intera Oncology
Key facts
| PMA number | P890055 |
|---|---|
| Trade name | MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM |
| Generic name | Pump, infusion, implanted, programmable |
| Applicant | Intera Oncology |
| Owner/operator | Boston Scientific Corporation |
| Product code | LKK |
| Approval date | Mar 11, 1996 |
| Docket number | 96M-0239 |
| Notice date | Jul 16, 1996 |
| Establishment registration | 3015537318 |
| FEI number | 3015537318 |
At a glance
- 10–99 Supplements
- Mar 16, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: