This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the stelid ii, stelix, and stelix ii endocardial pacing leads. The stelid ii, stelix, and stelix ii endocardial steroid eluting pacing leads are designed to be used with an implantable pacemaker for pacing and sensing of the heart. The stelid ii models btf25d/26d and utf25d/26d are intended for permanent pacing and sensing of the ventricle. The stelid ii models bjf24d/25d, stelix models br45d/46d, and stelix ii models brf25d/26d are intended for permanent pacing and sensing of the atrium.
| Device | STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD |
| Classification Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Generic Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Applicant | MicroPort CRM USA Inc. |
| Date Received | 2002-07-19 |
| Decision Date | 2004-06-17 |
| Notice Date | 2004-07-16 |
| PMA | P020030 |
| Supplement | S |
| Product Code | NVN |
| Docket Number | 04M-0310 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MicroPort CRM USA Inc. 5640 Airline Road arlington, TN 38002 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020030 | Original Filing | |
| S010 | 2013-09-11 | 30-day Notice |
| S009 | 2012-01-27 | 30-day Notice |
| S008 | 2011-02-28 | 30-day Notice |
| S007 | 2010-08-23 | 135 Review Track For 30-day Notice |
| S006 | 2010-03-30 | 30-day Notice |
| S005 | ||
| S004 | 2007-10-11 | 135 Review Track For 30-day Notice |
| S003 | 2006-05-25 | Real-time Process |
| S002 | 2005-07-21 | 135 Review Track For 30-day Notice |
| S001 | 2004-07-16 | Normal 180 Day Track |