- Device
- Adhesive; CapSure Sense Lead (4073,4074); CapSure Sense Lead (4574); CapSure SP Novus Lead (4092); CapSure SP Novus Lead
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S235
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2026-04-15
- Decision code
- OK30
- Date received
- 2026-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to reduce the bioburden monitoring frequency from bi-weekly to monthly