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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.
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP940031
Supplement NumberS011
Date Received10/24/1997
Decision Date04/30/1998
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the MERIDIAN(TM) and DISCOVER(TM) Pacemaker Systems to the current VIGOR family of pacemakers. The device, as modified, will be marketed under the trade name MERIDIAN(TM) and DISCOVERY(TM) Pacemaker Systems and is generally indicated for long-term cardiac pacing. Generally accepted indications for long-term cardiac pacing include, but are not limited to, sick sinus syndrome; chronic sinus arrhythmias, including sinus bradycardia, sinus arrest, and sinoatrial (SA) block; second-and third-degree atrioventricular (AV) block; bradycardia-tachycardia syndrome; and carotid sinus syndrome. Patients who demonstrate hemodynamic improvement from atrioventricular synchrony should be considered for one ofthe dual-chamber or atrial pacing modes. Dual-chamber modes are specifically indicated for treatment of atrioventricular synchrony, including varying degrees of AV block; low cardiac output or congestive heart failure related to bradycardia; and certain tachyarrhythmias. Teh adaptive-rate pacing modes of the pacemaker are indicated for patients exhibiting chronotropic incompetence and who would benefit by increase pacing rates concurrent with elevated metabolic demand.