- Device
- CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S199
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2021-11-10
- Decision code
- OK30
- Date received
- 2021-11-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the degreaser and degreaser system used at the supplier Lake Region Medical.