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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
Generic NameSYSTEM, ESOPHAGEAL PACING
ApplicantCARDIOCOMMAND, INC.
4920 WEST CYPRESS STREET
SUITE 110
TAMPA, FL 33607-3837
PMA NumberP840002
Supplement NumberS011
Date Received03/09/2004
Decision Date10/01/2004
Product Code LPA 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MANUFACTURING SITES LOCATED AT MARTECH MEDICAL PRODUCTS, BAJA CALIFORNIA, MEXICO AND HARLEYSVILLE, PENNSYLVANIA.
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