- Device
- VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P130010
- Supplement
- S005
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2026-01-15
- Decision code
- OK30
- Date received
- 2025-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- manufacturing process improvements for welding of pacing leads