PMA supplement
P980023 S013: KENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18
FDA PMA supplement · Normal 180 Day Track · Biotronik, Inc.
Key facts
| Original PMA | P980023 |
|---|---|
| Supplement number | S013 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | KENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18 |
| Generic name | TESTER, PACEMAKER ELECTRODE FUNCTION |
| Applicant | Biotronik, Inc. |
| Product code | DTA |
| Received date | Feb 19, 2003 |
| Decision date | Jul 29, 2003 |
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: