PMA
P100028: FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
FDA PMA · STENT, RENAL · Cook Medical Incorporated
Key facts
| PMA number | P100028 |
|---|---|
| Trade name | FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM |
| Generic name | STENT, RENAL |
| Applicant | Cook Medical Incorporated |
| Owner/operator | COOK MEDICAL |
| Product code | NIN |
| Approval date | Jan 14, 2011 |
| Docket number | 11M-0056 |
| Notice date | Jan 26, 2011 |
| Establishment registration | 3005580113 |
| FEI number | 3005580113 |
At a glance
- 1–9 Supplements
- Oct 8, 2014 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- No Withdrawn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: