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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.
 
DeviceDELTA/VISTA PACEMAKERS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
BOSTON SCIENTIFIC
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP840068
Supplement NumberS038
Date Received10/06/1999
Decision Date11/05/1999
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the Programmer Software Model 2881 version 1.3 and its labeling, used with the Model 2950 and Model 2901 PRM Prorammers, to correct software anomalies and update features.
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