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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVERITY ADX XL VDR MODEL 5456I PULSE GENERATOR
Generic Nameimplantable pacemaker Pulse-generator
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS098
Date Received12/02/2003
Decision Date01/30/2004
Product Codes DTB DXY KRG 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO MODIFY THE HEADER DESIGN OF A CURRENTLY MARKETED DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VERITY ADX XL VDR MODEL 5456I AND IS INDICATED AS FOLLOWS: THE VERITY ADX XL VDR MODEL 5456I IS INDICATED FOR USE ONLY WITH AV PLUS MODEL 1328C OR 1358C SINGLE-PASS IN-LINE QUADRIPOLAR LEADS (THE VERITY ADX XL VDR PACING SYSTEM). THE VERITY ADX XL VDR PACING SYSTEM IS INTENDED TO PROVIDE VDD OR VDDR PACING FOR PATIENTS WITH A HEALTHY SINUS NODE AND AV CONDUCTION ABNORMALITIES. THESE MODES ARE INDICATED FOR PATIENTS WHO NEED VENTRICULAR PACING WHEN ADEQUATE ATRIAL RATES AND ADEQUATE INTRACAVITARY ATRIAL COMPLEXES ARE PRESENT. THIS INCLUDES THE PRESENCE OF COMPLETE AV BLOCK WHEN: A) ATRIAL CONTRIBUTION IS NEEDED FOR HEMODYNAMIC BENEFIT, AND B) PACEMAKER SYNDROME HAD EXISTED OR IS ANTICIPATED. ADDITIONAL INDICATIONS INCLUDE NORMAL SINUS RHYTHM AND NORMAL AV CONDUCTION IN PATIENTS WHO INTERMITTENTLY NEED VENTRICULAR PACING.
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