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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.
 
DevicePRODIGY/THERA-I PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS128
Date Received10/09/2007
Decision Date11/09/2007
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE WORKSTATIONS USED FOR WELDING BATTERY HEADER SUBASSEMBLIES.
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