PMA supplement
P020009 S125: EXPRESS 2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEM
FDA PMA supplement · Normal 180 Day Track No User Fee · Boston Scientific Scimed, Inc.
Key facts
| Original PMA | P020009 |
|---|---|
| Supplement number | S125 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | EXPRESS 2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEM |
| Generic name | STENT, CORONARY |
| Applicant | Boston Scientific Scimed, Inc. |
| Product code | MAF |
| Received date | Jun 13, 2014 |
| Decision date | Dec 8, 2014 |
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: