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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.
 
DeviceORCHESTRA PROGRAMMER
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP980049
Supplement NumberS002
Date Received07/06/2000
Decision Date11/13/2000
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR ORCHESTRA PROGRAMMER WITH THE FOLLOWING APPLICATION SOFTWARE PACKAGES: MANAGER SOFTWARE APPLICATION VERSION 1.02, CSO A PROGRAMMER APPLICATION VERSION 2.21, CSO-WINDOWS PROGRAMMER APPLICATION VERSION 1.03, DEFENDER II PROGRAMMER APPLICATION VERSION 2.03, AND DEFENDER IV PROGRAMMER APPLICATION VERSION 1.03.
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