PMA supplement
P150028 S001: Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)
FDA PMA supplement · Panel Track · NuMED, Inc.
Key facts
| Original PMA | P150028 |
|---|---|
| Supplement number | S001 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) |
| Generic name | Aortic stent |
| Applicant | NuMED, Inc. |
| Product code | PNF |
| Received date | Feb 17, 2017 |
| Decision date | Oct 24, 2017 |
| Docket number | 17M-6290 |
| Notice date | Oct 27, 2017 |
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: