- Device
- CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline ActFix Lead, Vitatron Crystalline Active Fixation Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P930039
- Supplement
- S228
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2021-06-23
- Decision code
- OK30
- Date received
- 2021-06-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the cleaning process of stylet components manufactured at the supplier.