PMA
P180036: OPTIMIZER Smart System
FDA PMA · Implantable pulse generator · Impulse Dynamics (Usa), Inc.
Key facts
| PMA number | P180036 |
|---|---|
| Trade name | OPTIMIZER Smart System |
| Generic name | Implantable pulse generator |
| Applicant | Impulse Dynamics (Usa), Inc. |
| Owner/operator | Impulse Dynamics USA Inc |
| Product code | QFV |
| Approval date | Mar 21, 2019 |
| Docket number | 19M-1313 |
| Notice date | Mar 22, 2019 |
| Establishment registration | 3012563838 |
| FEI number | 3012563838 |
At a glance
- 10–99 Supplements
- Sep 24, 2026 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- No Withdrawn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: