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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 NameDELTA PACEMAKER SYSTRM; VIGOR DDD MODEL 950 (MASTER)
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
ApplicantGUIDANT CORP.
PMA NumberP840068
Supplement NumberS027
Date Received08/09/1995
Decision Date03/12/1996
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Aprpoval for adding an alternate lower profile connector top for the vigor ddd model 950 pacemaker.
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