PMA supplement
P960042 S031: SPECTRANETICS LASER SHEATH DEVICE
FDA PMA supplement · Normal 180 Day Track · Spectranetics (Philips)
Key facts
| Original PMA | P960042 |
|---|---|
| Supplement number | S031 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | SPECTRANETICS LASER SHEATH DEVICE |
| Generic name | DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS |
| Applicant | Spectranetics (Philips) |
| Product code | MFA |
| Received date | Sep 6, 2011 |
| Decision date | Apr 20, 2012 |
At a glance
- No Expedited review granted
- Yes 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: