PMA supplement
P110013 S088: Resolute Integrity Zotarolimus-Eluting Coronary Stent System
FDA PMA supplement · Panel Track · Medtronic Vascular
Key facts
| Original PMA | P110013 |
|---|---|
| Supplement number | S088 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Resolute Integrity Zotarolimus-Eluting Coronary Stent System |
| Generic name | Coronary drug-eluting stent |
| Applicant | Medtronic Vascular |
| Product code | NIQ |
| Received date | Jan 16, 2018 |
| Decision date | Dec 14, 2018 |
| Docket number | 18M-4778 |
| Notice date | Jan 28, 2019 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: