- Device
- CapSure Sense Lead (4074), CapSure Sense Lead (4574), Vitatron Crystalline Lead (ICM09B, ICM09JB)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S236
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2026-06-24
- Decision code
- OK30
- Date received
- 2026-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- reduced stability testing intervals for various cardiac lead families containing Dexamethasone or Beclomethasone Dipropionate