STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD
FDA premarket approval P020030 · decided 2004-06-17
Approval details
- PMA number
- P020030
- Trade name
- 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.
- Date received
- 2002-07-19
- Decision date
- 2004-06-17
- Days to decision
- 699 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- 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 A
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