PMA
P100009: MITRACLIP DELIVERY SYSTEM
FDA PMA · Mitral valve repair devices · ABBOTT MEDICAL
Key facts
| PMA number | P100009 |
|---|---|
| Trade name | MITRACLIP DELIVERY SYSTEM |
| Generic name | Mitral valve repair devices |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | NKM |
| Approval date | Oct 24, 2013 |
| Docket number | 13M-1365 |
| Notice date | Nov 15, 2013 |
| Establishment registration | 3007113487 |
| FEI number | 3007113487 |
At a glance
- 10–99 Supplements
- Jun 25, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: