Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: 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.; 5640 Airline Road; Arlington, TN 38002
• PMA Number: P130010
• Date Received: 05/06/2013
• Decision Date: 05/17/2023
• Product Code: NVN
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
Approval for the VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58).

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001