This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the introduction of the easyturn deployment mechanism. The device, as modified, will be marketed under the trade name stelix ii easyturn and is indicted for use with an implantable pacemaker. They are intended for permanent pacing and sensing of the atrium.
| Device | STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS |
| Classification Name | Permanent Defibrillator Electrodes |
| Generic Name | Permanent Defibrillator Electrodes |
| Applicant | MicroPort CRM USA Inc. |
| Date Received | 2004-07-16 |
| Decision Date | 2004-11-22 |
| PMA | P020030 |
| Supplement | S001 |
| Product Code | NVY |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MicroPort CRM USA Inc. 5640 Airline Road arlington, TN 38002 |
| 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 |