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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 NameSTAT PACE II
Classification Namesystem, esophageal pacing
Generic Nameexternal pulse generator
ApplicantCARDIO COMMAND
PMA NumberP840002
Supplement NumberS011
Date Received03/09/2004
Decision Date10/01/2004
Product Code
LPA[ Registered Establishments with LPA ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for manufacturing sites located at martech medical products, baja california, mexico and harleysville, pennsylvania.
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