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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.
 
DeviceMEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATION SOFTWARE
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS032
Date Received08/29/2003
Decision Date02/20/2004
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ENPULSE IMPLANTABLE PULSE GENERATOR MODELS E2DR01, E2DR03, E2DR06, E2DR21, E2DR31, E2DR33, E2D01, E2D03, E2VDD01, E2SR01, E2SR03, E2SR06 WITH ATRIAL CAPTURE MANAGEMENT AND MODEL 9991 APPLICATION SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENPULSE IPG AND IS INDICATED AS FOLLOWS: ENPULSE PACEMAKERS ARE INDICATED FOR USE IN PATIENTS WHO ARE EXPERIENCING ACCEPTED CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: 1) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREE AV BLOCK 2) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK 3) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS. 4) BRADYCARDIA-TACHYCARDIA SYNDROME 5) VASOVAGAL SYNDROMES OR HYPERSENSITITVE CAROTID SINUS SYNDROMES. ENPULSE PACEMAKERS ARE ALSO INDICATED FOR USE IN PATIENTS WHO MAY BENEFIT FROM RATE RESPONSIVE PACING TO SUPPORT CARDIAC OUTPUT DURING VARYING LEVELS OF ACTIVITY. USING RATE RESPONSE MODES MAY RESTORE HEART RATE VARIABILITY BY IMPROVING CARDIAC OUTPUT. THESE DEVICES ARE ALSO INDICATED FOR USE IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY THROUGH THE USE OF DUAL CHAMBER MODES AND ATRIAL TRACKING MODES. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY. DUAL CHAMBER MODES ARE INDICATED FOR USE IN PATIENTS WHO HAVE EXPERIENCED ONE OR BOTH OF THE FOLLOWING CONDITIONS. 1) VARIOUS DEGREES OF AV BLOCK 2) VVI INTOLERANCE (FOR EXAMPLE, PACEMAKER SYNDROME) IN PRESENCE OF PERSISTENT SINUS RHYTHM. THE DEVICE IS ALSO INDICATED FOR VDD PACING IN PATIENTS WHO HAVE ADEQUATE RATES AND ON OR BOTH OF THE FOLLOWING CONDITIONS. 1) A REQUIREMENT FOR VENTRICULAR PACING WHEN ADEQUATE ATRIAL RATES AND ADEQUATE INTRACAVITARY ATRIAL COMPLEXES ARE PRESENT. THIS INCLUDES THE PRESENCE OF COMPLETE AV BLOCK WHEN ATRIAL CONTRIBUTION IS NEEDED FOR HEMODYNAMIC BENEFIT OR WHEN...
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