PMA supplement
P950020 S012: ULTRA2 CUTTING BALLOON MONORAIL(MR)
FDA PMA supplement · Normal 180 Day Track No User Fee · Boston Scientific Corp
Key facts
| Original PMA | P950020 |
|---|---|
| Supplement number | S012 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ULTRA2 CUTTING BALLOON MONORAIL(MR) |
| Generic name | Catheter, angioplasty, peripheral, transluminal |
| Applicant | Boston Scientific Corp |
| Product code | LIT |
| Received date | Nov 8, 2004 |
| Decision date | Mar 16, 2005 |
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: