PMA supplement
P960042 S053: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH
FDA PMA supplement · Special (Immediate Track) · Spectranetics (Philips)
Key facts
| Original PMA | P960042 |
|---|---|
| Supplement number | S053 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH |
| Generic name | DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS |
| Applicant | Spectranetics (Philips) |
| Product code | MFA |
| Received date | Mar 14, 2016 |
| Decision date | Apr 13, 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: