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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEDTRONIC SIGMA SERIES PULSE GENERATORS AND MODEL 9963/A SOFTWARE
ApplicantMEDTRONIC VASCULAR
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 - component
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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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