PMA supplement
P050018 S006: ANGIOSCULPT PTCA SCORING BALLOON CATHETER
FDA PMA supplement · 135 Review Track For 30-Day Notice · Spectranetics Corp.
Key facts
| Original PMA | P050018 |
|---|---|
| Supplement number | S006 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ANGIOSCULPT PTCA SCORING BALLOON CATHETER |
| Generic name | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring |
| Applicant | Spectranetics Corp. |
| Product code | NWX |
| Received date | May 18, 2009 |
| Decision date | Oct 30, 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: