PMA supplement
P960042 S003: 14FR. AND 16FR. LASER SHEATH KIT AND FISH TAPE
FDA PMA supplement · Normal 180 Day Track · Spectranetics (Philips)
Key facts
| Original PMA | P960042 |
|---|---|
| Supplement number | S003 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | 14FR. AND 16FR. LASER SHEATH KIT AND FISH TAPE |
| Applicant | Spectranetics (Philips) |
| Received date | Aug 14, 1998 |
| Decision date | Feb 8, 1999 |
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: