VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)
PMA P130010
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP130010 | Date17 May 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- FDA applicant
- MicroPort CRM S.r.l.
- PMA Number
- FDA Product Code
- NVN
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The VEGA Steroid-Eluting Endocardial Leads are drug-eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes designed for cardiac pacing applications. These leads are manufactured by MicroPort CRM USA, Inc. and are available in three models: VEGA R45, VEGA R52, and VEGA R58.
These leads are intended for implantation in the heart to deliver electrical pacing signals. The VEGA Steroid-Eluting Endocardial Leads are FDA PMA approved and are supplied as sterile devices. They are designed for permanent implantation and should be stored according to the manufacturer's instructions.
Other devices from MicroPort CRM USA, Inc.
Questions
AI-generated answers, 18 Sep 2026
What are the VEGA Steroid-Eluting Endocardial Leads used for?
The VEGA Steroid-Eluting Endocardial Leads are used as drug-eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes. They are designed to deliver electrical pacing signals to the heart for patients who require cardiac pacing therapy.
What are the different models of VEGA Steroid-Eluting Endocardial Leads available?
The VEGA Steroid-Eluting Endocardial Leads are available in three models: VEGA R45, VEGA R52, and VEGA R58. Each model may have specific design characteristics suitable for different patient anatomies or clinical requirements.
What regulatory approvals do the VEGA Steroid-Eluting Endocardial Leads have?
The VEGA Steroid-Eluting Endocardial Leads have received FDA PMA (Premarket Approval) with the approval number P130010. This indicates that the device has been evaluated by the FDA and found to have sufficient evidence of safety and effectiveness for its intended use.