PMA
P080012: PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
FDA PMA · Pump, infusion, implanted, programmable · Infusyn Therapeutics, LLC
Key facts
| PMA number | P080012 |
|---|---|
| Trade name | PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM |
| Generic name | Pump, infusion, implanted, programmable |
| Applicant | Infusyn Therapeutics, LLC |
| Owner/operator | Infusyn Therapeutics |
| Product code | LKK |
| Approval date | Feb 7, 2012 |
| Docket number | 12M-0180 |
| Notice date | Feb 27, 2012 |
| Establishment registration | 3030198397 |
| FEI number | 3030198397 |
At a glance
- 10–99 Supplements
- Jun 18, 2025 Latest supplement decision
- No Withdrawn
- Yes 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: