CAPSURE SENSE MRI SURESCAN LEAD MODEL 4574
FDA premarket approval P830061/S143 · decided 2017-04-25
Approval details
- PMA number
- P830061
- Supplement
- S143
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CAPSURE SENSE MRI SURESCAN LEAD MODEL 4574
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-01-25
- Decision date
- 2017-04-25
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for 1.5 and 3T MR Conditional labeling for MRI SureScan Lead Model 6946M.
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