PMA supplement
P860019 S234: MAVERICK2 MONORAIL (MR), MAVERICK OVER-THE-WIRE (OTW), QUANTUM MAVERICK MR AND OTW
FDA PMA supplement · 135 Review Track For 30-Day Notice · Scimed Life Systems, Inc.
Key facts
| Original PMA | P860019 |
|---|---|
| Supplement number | S234 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | MAVERICK2 MONORAIL (MR), MAVERICK OVER-THE-WIRE (OTW), QUANTUM MAVERICK MR AND OTW |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Scimed Life Systems, Inc. |
| Product code | LOX |
| Received date | Apr 10, 2009 |
| Decision date | Sep 18, 2009 |
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: