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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 SIGMA SERIES PULSE GENERATORS AND MODEL 9963/A SOFTWARE
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS002
Date Received03/10/1999
Decision Date08/09/1999
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  
Sigma family of pulse generators & software. The DR & SR series are indicated for rate adaptive pacing in pts who may benefit fr increased pacing rates concurrent w/increases in activity. The DR & D Series, SR & S Series, & VVI series are indicated for accepted pt conditions warranting chronic cardiac pacing which include:Symptomatic paroxysmal or permanent second- or third-degree AV block; Symptomatic bilateral bundle branch block; Symptomatic paroxysmal or transient sinus node dysfunctions w/or w/o associated AV conduction disorders; Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias.The DR & D series pacemakers are also indicated for dual chamber & atrial tracking modes in pts whomay benefit fr maintenance of AV synchrony.Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate & AV synchrony, which include:Various degrees of AV block to maintain the atrial contribution to cardiac output; VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. The pulse generator, Medtronic.Sigma(TM) Model SVDD303 Pulse Generator is indicated for the following: accepted patient conditions warranting chronic cardiac pacing which includes: Symptomatic paroxysmal or permanent second- or third-degree AV block; Symptomatic bilateral bundel branch block. These pacemakers are also indicated for dual chamber & atrial tracking modes in pts who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate & AV synchrony, which include: various degrees of AV block to maintain the atrial contribution to cardiac output; VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. The VDD Series pacemakers are also indicated for VDD modes in pts having adequae atrial rates & various indications.
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