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Device | STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS |
Generic Name | Permanent defibrillator electrodes |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P020030 |
Supplement Number | S001 |
Date Received | 07/16/2004 |
Decision Date | 11/22/2004 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement 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. |