- Device
- SelectSecure Lead
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P030036
- Supplement
- S120
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2020-05-11
- Decision code
- OK30
- Date received
- 2020-05-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Iimplementation of a welding rework process and a microscope’s reticle to perform the scratches inspection.