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 a change involving alternate process parameters for the manufacturing of materials in the steroid collar components.
| Device | STELID II, STELIX, AND STLIX II STEROID-ELUTING PACING LEADS |
| Generic Name | Permanent Defibrillator Electrodes |
| Applicant | MicroPort CRM USA Inc. |
| Date Received | 2007-10-11 |
| Decision Date | 2008-10-17 |
| PMA | P020030 |
| Supplement | S004 |
| Product Code | NVY |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |