PMA
P000049: CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD
FDA PMA · Transcatheter septal occluder · Nmt Medical, Inc.
Key facts
| PMA number | P000049 |
|---|---|
| Trade name | CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD |
| Generic name | Transcatheter septal occluder |
| Applicant | Nmt Medical, Inc. |
| Product code | MLV |
| Approval date | Dec 5, 2001 |
| Docket number | 02M-0272 |
| Notice date | Jun 27, 2002 |
| FEI number | 1000120899 |
At a glance
- 10–99 Supplements
- Mar 5, 2009 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: