PMA supplement
P000039 S060: THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM
FDA PMA supplement · Normal 180 Day Track No User Fee · ABBOTT MEDICAL
Key facts
| Original PMA | P000039 |
|---|---|
| Supplement number | S060 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM |
| Generic name | Transcatheter septal occluder |
| Applicant | ABBOTT MEDICAL |
| Product code | MLV |
| Received date | Oct 30, 2017 |
| Decision date | Apr 26, 2018 |
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: