- Device
- Medtronic SelectSecure MRI SureScan Lead
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P030036
- Supplement
- S117
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2020-02-03
- Decision code
- OK30
- Date received
- 2020-01-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the dispensing volume of Beclomethasone Dipropionate solution used in SelectSecure 3830 leads.