MEDTRONIC SELECTSECURE LEAD MODEL 3830
FDA premarket approval P030036 · decided 2005-08-03
Approval details
- PMA number
- P030036
- Trade name
- MEDTRONIC SELECTSECURE LEAD MODEL 3830
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2003-09-04
- Decision date
- 2005-08-03
- Days to decision
- 699 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE SELECTSECURE LEAD MODEL 3830. THE MODEL 3830 LEAD HAS APPLICATIONS WHERE IMPLANTABLE ATRIAL OR VENTRICULAR, SINGLE-CHAMBER OR DUAL-CHAMBER PACING SYSTEMS ARE INDICATED. THE MODEL 3830 LEAD IS INTENDED FOR PACING AND SENSING IN THE ATRIUM OR VENTRICLE.
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