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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 NameVIGOR MODEL 2880 SOFTWARE APPLICATION
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
ApplicantGUIDANT CORP.
PMA NumberP840068
Supplement NumberS029
Date Received03/25/1996
Decision Date11/07/1996
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
1)new programming system, with model 2901 prm programming system with the commercially available vigor family of pulse generators and accessories, and 2)a new manufacturing contract facility, emd associates, inc. , (emd), 4065 theurer blvd. , winona, mn 55987.
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