MLV · Transcatheter Septal Occluder
· Class 3
Overview
| Product Code | MLV |
|---|---|
| Device Name | Transcatheter Septal Occluder |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
Approved PMA: P000039
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P120021 | AMPLATZER PFO OCCLUDER | ABBOTT MEDICAL | Oct 28, 2016 | APPR |
| P040040 | AMPLATZER MUSCULAR VSD OCCLUDER | ABBOTT MEDICAL | Sep 7, 2007 | APPR |
| P050006 | GORE HELEX SEPTAL OCCLUDER | W. L. Gore & Associates, Inc. | Aug 11, 2006 | APPR |
| P000049 | CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD | Nmt Medical, Inc. | Dec 5, 2001 | APPR |
| P000039 | THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM | ABBOTT MEDICAL | Dec 5, 2001 | APPR |
Top Applicants
- ABBOTT MEDICAL — 3 clearances
- W. L. Gore & Associates, Inc. — 1 clearance
- Nmt Medical, Inc. — 1 clearance
