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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 - 200-0010, 200-0025, 250-0010, 250-0025
Generic NameSYSTEM, ESOPHAGEAL PACING
ApplicantCardio Command
4920 W. Cypress St.
Suite 110
Tampa, FL 33607
PMA NumberP860008
Supplement NumberS023
Date Received05/16/2017
Decision Date06/19/2017
Product Code LPA 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
New supplier for the molding of the pacing wire connector.
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