VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58)
FDA premarket approval P130010 · decided 2023-05-17
Approval details
- PMA number
- P130010
- Trade name
- VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58)
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2013-05-06
- Decision date
- 2023-05-17
- Days to decision
- 3663 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for the VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58).
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