PMA supplement
P950005 S006: CELLSIUS INTERFACE CABLES (AUTOCLAVABLE)
FDA PMA supplement · Biosense Webster, Inc.
Key facts
| Original PMA | P950005 |
|---|---|
| Supplement number | S006 |
| Trade name | CELLSIUS INTERFACE CABLES (AUTOCLAVABLE) |
| Generic name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
| Applicant | Biosense Webster, Inc. |
| Product code | DRF |
| Received date | Aug 2, 1999 |
| Decision date | Feb 1, 2000 |
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: