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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 ESOPHAGEAL PACING SYSTEM
Classification Namesystem, esophageal pacing
Generic Nameexternal pulse generator
ApplicantSEECOR, INC.
PMA NumberP840002
Supplement NumberS009
Date Received01/21/1997
Decision Date09/03/1997
Product Code
LPA[ Registered Establishments with LPA ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design and labeling modification to the tapsystem 2a and the stat-pace ii esophageal pacing systems.
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