PMA
P800036: INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
FDA PMA · Pump, infusion, implanted, programmable · Intera Oncology
Key facts
| PMA number | P800036 |
|---|---|
| Trade name | INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4 |
| Generic name | Pump, infusion, implanted, programmable |
| Applicant | Intera Oncology |
| Owner/operator | Boston Scientific Corporation |
| Product code | LKK |
| Approval date | Mar 3, 1982 |
| Docket number | 82M-0072 |
| Notice date | Mar 26, 1982 |
| Establishment registration | 3015537318 |
| FEI number | 3015537318 |
At a glance
- 10–99 Supplements
- Feb 7, 2020 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- Yes Withdrawn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: