PMA
P140032: Implantable System for Remodulin
FDA PMA · Pump, infusion, implanted, programmable · Medtronic, Inc.
Key facts
| PMA number | P140032 |
|---|---|
| Trade name | Implantable System for Remodulin |
| Generic name | Pump, infusion, implanted, programmable |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | LKK |
| Approval date | Dec 22, 2017 |
| Docket number | 17M-6984 |
| Notice date | Jan 9, 2018 |
| Establishment registration | 3001504994 |
| FEI number | 3001504994 |
At a glance
- 10–99 Supplements
- Aug 31, 2021 Latest supplement decision
- Yes Withdrawn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: