PMA supplement
P890017 S010: PALMAZ BALLOON-EXPANDABLE STENT
FDA PMA supplement · Panel Track · Cordis US Corporation
Key facts
| Original PMA | P890017 |
|---|---|
| Supplement number | S010 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | PALMAZ BALLOON-EXPANDABLE STENT |
| Generic name | STENT, RENAL |
| Applicant | Cordis US Corporation |
| Product code | NIN |
| Received date | Dec 6, 2001 |
| Decision date | Jul 10, 2002 |
| Docket number | 02M-0348 |
| Notice date | Aug 8, 2002 |
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: