Vega Endocardial Pacing Leads
FDA premarket approval P130010/S003 · decided 2025-04-15
Approval details
- PMA number
- P130010
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Vega Endocardial Pacing Leads
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2024-06-25
- Decision date
- 2025-04-15
- Days to decision
- 294 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- approval for changes to the design of a distal tip component and internal lead body insulation supplier.
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