PMA supplement
P030047 S029: PRECISE, PRECISE RX AND PRECISE PRO RX NITINOL STENT SYSTEM
FDA PMA supplement · 135 Review Track For 30-Day Notice · Cordis US Corporation
Key facts
| Original PMA | P030047 |
|---|---|
| Supplement number | S029 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | PRECISE, PRECISE RX AND PRECISE PRO RX NITINOL STENT SYSTEM |
| Generic name | Stent, carotid |
| Applicant | Cordis US Corporation |
| Product code | NIM |
| Received date | Mar 19, 2015 |
| Decision date | Nov 25, 2015 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: