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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.
 
DeviceTAPSCOPE 550
Classification Namesystem, esophageal pacing
Generic Namesystem, esophageal pacing
Applicant
CARDIO COMMAND
4920 west cypress st. ste.110
tampa, FL 33607
PMA NumberP860008
Supplement NumberS021
Date Received02/29/2012
Decision Date06/05/2012
Product Code
LPA[ Registered Establishments with LPA ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OF A NEW SUPPLIER FOR THE MOLDING OF THE PACING WIRE CONNECTOR AND REVISION TO THE MANUFACTURING PROCESS OF THE PACING WIRE ASSEMBLY.
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