Identification of the person placing the product on the market
Bulmed 2000 LTD
EIK
121268853
BG
SOF
Sofia
1680
Lyudmil Borisov Parvanov
02/9580481,9580482
marketing@bulmed2000-bg.com
Identification of the wholesaler
Bulmed 2000 LTD
EIK
121268853
BG
SOF
Sofia
1680
Lyudmil Borisov Parvanov
02/9580481,9580482
marketing@bulmed2000-bg.com
IV-Р-Т/МИ234
03/01/2008
General medical information about the device
01 - Active implantable medical devices
Active implantable medical devices
Cardiovascular system
GMDN
34398
Accent MRI DR
PM2224
Description of the medical device
Sterility, Hospital prescription
Intended action by the manufacturer
The Accent MRI pacemaker has been designed and tested for safe
performance of a full-body MRI scan, without zone restrictions,1 using a 1,5 T
(Tesla) field-strength MRI scanner.1 The MRI conditional device:
– Allows a maximum whole body averaged specific absorption rate (SAR) of
4 watts per kilogram (W/kg) for high image resolution
– Must be used in conjunction with an MRI lead from St. Jude Medical
n An optional, easy-to-use hand-held device (SJM MRI Activator™ device) can be
used to program the device to pre-approved MRI settings pre- and post-MRI
scan, decreasing the number of workflow steps and increasing clinic efficiency
n InvisiLink™ wireless telemetry in conjunction with the Merlin@home™ transmitter
and Merlin.net™ Patient Care Network (PCN), allows for daily remote monitoring
and follow-up.
n AT/AF Alerts can be programmed to notify patients and/or their clinics when
a programmed AT/AF threshold or continuous episode duration has been
exceeded, or when a high ventricular rate accompanies the AT/AF episode
n A suite of state-of-the-art features—complete automaticity (atrial and
ventricular), Ventricular Intrinsic Preference (VIP™) technology, QuickOpt™
timing cycle optimisation, the AF Suppression™ algorithm and SenseAbility™
technology—is designed to deliver optimal therapy for patients at implant and
throughout their lives
n Industry-leading longevity offers 9,1 years of service life,2 which is supported
by a 7-year warranty3
