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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 NameDISCOVERY/MERIDIAN PACEMAKER SYSTEMS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual-chamber adaptive-rate pacemaker
ApplicantGUIDANT CORP.
PMA NumberP940031
Supplement NumberS021
Date Received10/04/1999
Decision Date10/20/1999
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software application model 2890 revision 3. 27 which removes automatic minute ventilation (mv) initialization, adds a "pop-up" warning ont he programmer screen prior to manual mv initialization, and corrects several minor anomalies applicable to the entire pdm pacemaker line.
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