PMA supplement
P860019 S264: APEX MONORAIL & APEX OTW PTCA DILATATION CATHETER/MAVERICK2 MONORAIL PTCA CATHETER/MAVERICK OTW PTCA CATHETER/MAVERICK
FDA PMA supplement · 135 Review Track For 30-Day Notice · Scimed Life Systems, Inc.
Key facts
| Original PMA | P860019 |
|---|---|
| Supplement number | S264 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | APEX MONORAIL & APEX OTW PTCA DILATATION CATHETER/MAVERICK2 MONORAIL PTCA CATHETER/MAVERICK OTW PTCA CATHETER/MAVERICK |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Scimed Life Systems, Inc. |
| Product code | LOX |
| Received date | Oct 7, 2010 |
| Decision date | Mar 31, 2011 |
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: