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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSTAT-PACE II ESOPHAGEAL PACING SYSTEM
Classification Namesystem, esophageal pacing
Generic Namesystem, esophageal pacing
Applicant
CARDIOCOMMAND, INC.
4920 west cypress street
suite 110
tampa, FL 33607-3837
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/material
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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