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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.
 
DeviceSYMPHONY DR/SR & ELA RHAPSODY +DR/DR/SR
Generic NamePulse generator, permanent, implantable
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP950029
Supplement NumberS037
Date Received06/23/2008
Decision Date07/23/2008
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MANUFACTURING PROCESS CHANGES ENHANCING THE QUALITY CONTROLS PERTAINING TO SYMPHONY AND RHAPSODY PACEMAKERS AS WELL AS OVATIO ICD AND CRT-D SYSTEM DEVICES.
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