PMA
P200032: Occlutech® ASD Occluder and Occlutech® Pistol Pusher
FDA PMA · Transcatheter septal occluder (atrial) · Occlutech Holding AG
Key facts
| PMA number | P200032 |
|---|---|
| Trade name | Occlutech® ASD Occluder and Occlutech® Pistol Pusher |
| Generic name | Transcatheter septal occluder (atrial) |
| Applicant | Occlutech Holding AG |
| Owner/operator | Occlutech Holding AG |
| Product code | OZG |
| Approval date | Dec 29, 2023 |
| Docket number | 24M-0759 |
| Notice date | Feb 21, 2024 |
| Establishment registration | 3014616394 |
| FEI number | 3014616394 |
At a glance
- 1–9 Supplements
- Jun 5, 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- No Withdrawn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: