- Device
- Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S207
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2022-06-01
- Decision code
- OK30
- Date received
- 2022-05-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the FACTORYWorks Manufacturing Execution System to Release 9.10.