Medtronic SelectSecure MRI SureScan Lead
FDA premarket approval P030036/S139 · decided 2022-10-03
Approval details
- PMA number
- P030036
- Supplement
- S139
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Medtronic SelectSecure MRI SureScan Lead
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2022-07-22
- Decision date
- 2022-10-03
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval to expand the indications for use for the Medtronic SelectSecure MRI SureScan Lead Model 3830 to include pacing at the left bundle branch area as an alternative to right ventricular pacing.
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