- Device
- CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P850089
- Supplement
- S148
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2020-07-22
- Decision code
- OK30
- Date received
- 2020-06-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Test method updates including technical content changes based on test method validation reports.