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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.
 
DeviceSTAT PACE II
Classification Namesystem, esophageal pacing
Generic Namesystem, esophageal pacing
Applicant
CARDIOCOMMAND, 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 Product No
Approval Order Statement 
Approval for manufacturing sites located at martech medical products, baja california, mexico and harleysville, pennsylvania.
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