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. |
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Device | ORCHESTRA PROGRAMMER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S002 |
Date Received | 07/06/2000 |
Decision Date | 11/13/2000 |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH 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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