Premarket Approval (PMA)

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 Name: MEDTRONIC MODEL P1501DR ENRHYTHM IMPLANTABLE PULSE GENERATOR, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND MEDTRONIC MO
• Classification Name: implantable pacemaker pulse-generator
• Generic Name: implantable pulse generator programming software
• Regulation Number: 870.3610
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P980035
• Supplement Number: S038
• Date Received: 04/27/2004
• Decision Date: 04/28/2005
• Product Code: DXY [ Registered Establishments with DXY ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: change design/components/specifications - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the medtronic model p1501dr enrhythm implantable pulse generator, medtronic model 9987 application software and medtronic model 2696 incheck patient assistant. The cevice is indicate for the follwoing: 1) rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity. 2) accepted patient 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 with or without associated av conduction disorders, and bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias. The device is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of av synchrony. Dual chamber modes are specifically indicated for treatment of cinduction disorders that require restoration of both rate and av synchrony, hich include: various degrees of av block to maintain the atrial contribution to cardiac output and vvi intolerance (e. G. , pacemaker syndrome) in the presence of persistent siuns rhythm. Antitachycardia pacing (atp) is indicated for terminatino of atrial tachyarrhymias in bradycardia patients with one or more of the above pacing indications. Atrial rhythm management features such as atrial rate stabilization (ars), atrial preference pacing (app), and post mode switch overdrive pacing (pmop) are indicated for the suppression of atrial tachyarrhythmias in bradycardia patients with atrial septal lead placement and one or more of the above pacing indications.