PMA
P120009: NIT-OCCLUD PDA
FDA PMA · OCCLUDER, PATENT DUCTUS, ARTERIOSUS · Pfm Medical, Inc.
Key facts
| PMA number | P120009 |
|---|---|
| Trade name | NIT-OCCLUD PDA |
| Generic name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
| Applicant | Pfm Medical, Inc. |
| Owner/operator | PFM MEDICAL, INC |
| Product code | MAE |
| Approval date | Aug 16, 2013 |
| Docket number | 13M-0988 |
| Notice date | Aug 26, 2013 |
| Establishment registration | 3013666218 |
| FEI number | 3013666218 |
At a glance
- 1–9 Supplements
- Oct 17, 2024 Latest supplement decision
- No Withdrawn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: