Basic Information
- Trade Name
- MEDTRONIC SIGMA SERIES PULSE GENERATORS AND MODEL 9963/A SOFTWARE
- PMA Number
- P980035
- Supplement Number
- S002
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 9, 1999
- Date Received
- March 10, 1999
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.