- Device
- CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P930039
- Supplement
- S216
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2020-10-26
- Decision code
- OK30
- Date received
- 2020-10-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to the cell operating system transformation of screw-in distal assembly manufacturing process.