PMA supplement
P950020 S091: Wolverine Coronary Cutting Balloon Monorail Over The Wire
FDA PMA supplement · 30-Day Notice · Boston Scientific Corp
Key facts
| Original PMA | P950020 |
|---|---|
| Supplement number | S091 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Wolverine Coronary Cutting Balloon Monorail Over The Wire |
| Generic name | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring |
| Applicant | Boston Scientific Corp |
| Product code | NWX |
| Received date | Oct 5, 2018 |
| Decision date | Oct 31, 2018 |
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: