PMA
P110004: PRESILLION PLUS COCR CORONARY STENT RX SYSTEM
FDA PMA · STENT, CORONARY · Medinol, Ltd.
Key facts
| PMA number | P110004 |
|---|---|
| Trade name | PRESILLION PLUS COCR CORONARY STENT RX SYSTEM |
| Generic name | STENT, CORONARY |
| Applicant | Medinol, Ltd. |
| Owner/operator | MEDINOL LTD. |
| Product code | MAF |
| Approval date | Apr 12, 2012 |
| Docket number | 12M-0407 |
| Notice date | May 1, 2012 |
| Establishment registration | 3003084171 |
| FEI number | 3003084171 |
At a glance
- 10–99 Supplements
- Apr 9, 2020 Latest supplement decision
- Yes Withdrawn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: