HDE supplement
H000007 S004: AMPLATZER PFO OCCLUDER
FDA HDE supplement · special (immediate track) · AGA MEDICAL CORP.
Key facts
| Original HDE | H000007 |
|---|---|
| Supplement number | S004 |
| Supplement type | special (immediate track) |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | AMPLATZER PFO OCCLUDER |
| Generic name | Transcatheter septal occluder |
| Applicant | AGA MEDICAL CORP. |
| Product code | MLV |
| Received date | Aug 29, 2003 |
| Decision date | Oct 31, 2003 |
| Docket number | 02M-0167 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: