PMA supplement
P850089 S045: MEDTRONIC(R) CAPSURE(R) NOVUS STEROID ELUTING, BIPOLAR, TRANSVENOUS PACING LEAD MODELS 5054 AND 5554
FDA PMA supplement · Real-Time Process · Medtronic Cardiac Rhythm Disease Management
Key facts
| Original PMA | P850089 |
|---|---|
| Supplement number | S045 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MEDTRONIC(R) CAPSURE(R) NOVUS STEROID ELUTING, BIPOLAR, TRANSVENOUS PACING LEAD MODELS 5054 AND 5554 |
| Generic name | Permanent pacemaker Electrode |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Product code | DTB |
| Received date | Dec 7, 2000 |
| Decision date | Jan 8, 2001 |
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: