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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 SYSTEM
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP840068
Supplement NumberS048
Date Received04/04/2011
Decision Date05/17/2011
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an update to the model 2909 system software v8. 01 and the addition of model 2905 pdf report generator v1. 01.
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