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Device | STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD |
Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P020030 |
Date Received | 07/19/2002 |
Decision Date | 06/17/2004 |
Product Code |
NVN |
Docket Number | 04M-0310 |
Notice Date | 07/16/2004 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S006 S007 S008 S009 S010 |