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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.
Classification Nameprogrammer, pacemaker
Generic Namepulse generator, programmer
Regulation Number870.3700
PMA NumberP940031
Supplement NumberS005
Date Received03/25/1996
Decision Date11/07/1996
Product Code
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 
Approval for 1)a new programming system, the model 2901 prm programming system with the commercially available vigor family of pulse generators and accessories, and 2) a new manufacturing cotract faciliyt, emd associates, inc. , (emd), 4065 theurer blvd. , winona, mn 55987.