PMA supplement
P960042 S019: SPECTRANETICS LASER SHEATH II PRODUCTS
FDA PMA supplement · 30-Day Notice · Spectranetics (Philips)
Key facts
| Original PMA | P960042 |
|---|---|
| Supplement number | S019 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | SPECTRANETICS LASER SHEATH II PRODUCTS |
| Generic name | DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS |
| Applicant | Spectranetics (Philips) |
| Product code | MFA |
| Received date | Aug 2, 2010 |
| Decision date | Sep 1, 2010 |
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: