PMA supplement
P950020 S072: WOLVERINE CORONARY CUTTING BALLOON (MONORAIL & OVER-THE-WIRE)
FDA PMA supplement · Normal 180 Day Track · Boston Scientific Corp
Key facts
| Original PMA | P950020 |
|---|---|
| Supplement number | S072 |
| Supplement type | Normal 180 Day Track |
| 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 | Jan 29, 2016 |
| Decision date | Aug 18, 2016 |
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: