SelectSecure MRI SureScan Lead
FDA premarket approval P030036/S100 · decided 2018-06-28
Approval details
- PMA number
- P030036
- Supplement
- S100
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- 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
- 2018-04-13
- Decision date
- 2018-06-28
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for an update to the indications for use to include pacing at the bundle of His.
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