PMA P030036S100
- Device
- SelectSecure MRI SureScan Lead
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P030036
- Supplement
- S100
- Product code
- NVN
- Decision date
- 2018-06-28
- Classification
- Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Approval for an update to the indications for use to include pacing at the bundle of His.
Current openFDA PMA Record#
- Device
- SelectSecure MRI SureScan Lead
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P030036
- Supplement
- S100
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2018-06-28
- Decision code
- APPR
- Date received
- 2018-04-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an update to the indications for use to include pacing at the bundle of His.