PMA supplement
P000039 S046: AMPLATZER SEPTAL AND CRIBRIFORM OCCLUDERS
FDA PMA supplement · 30-Day Notice · ABBOTT MEDICAL
Key facts
| Original PMA | P000039 |
|---|---|
| Supplement number | S046 |
| Supplement type | 30-Day Notice |
| Trade name | AMPLATZER SEPTAL AND CRIBRIFORM OCCLUDERS |
| Generic name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
| Applicant | ABBOTT MEDICAL |
| Product code | MAE |
| Received date | May 14, 2012 |
| Decision date | Jun 6, 2012 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: