This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Revo MRI SureScan Pacing System PMA Applicant: Address:
PMA Applicant:Medtronic, Inc.
Address:8200 Coral Sea Street N.E. , Mounds View, MN 55112
Approval Date: February 8, 2011 Approval Letter:
What is it? The Revo MRI SureScan Pacing System is designed to deliver standard pacing therapy in patients who have slow heart rates (bradycardia). Unlike most other pacing systems, the Revo MRI SureScan Pacing System has been specifically designed and tested to allow patients implanted with the device to receive a magnetic resonance imaging (MRI) scan if certain conditions are met. This device is therefore labeled as MR Conditional and is the first pacing system labeled as such.
How does it work? The device delivers electrical pulses to the heart to start cardiac contractions.
When is it used? The device is implanted in patients who have slow heart rates.
What will it accomplish? The device performs appropriately in the MRI environment, under specific conditions, and provides standard pacing therapy.
When should it not be used? The device should not be used in patients who already have another pacemaker or defibrillator implanted or in patients who need certain kinds of pacing therapies that this device does not provide.
Additional information: Summary of Safety and Effectiveness and labeling are available online.