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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 Namepulse-generator, single chamber, single
Generic Namepulse-generator, single chamber, single
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP860007
Supplement NumberS021
Date Received10/25/1999
Decision Date12/02/1999
Product Code
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the manufacturing and labeling facility located at guidant corp. , st. Paul, mn 55112-5798.