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 | SMARTVIEW |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P900022 |
Supplement Number | S010 |
Date Received | 03/05/2008 |
Decision Date | 03/18/2008 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE SMARTVIEW 2.02 UG3 SOFTWARE. THE SOFTWARE MODIFICATIONS ARE INTENDED TO MAKE MINOR SOFTWARE CORRECTIONS AND TO ADD THE PACEART XML CONVERTER TO THE SMARTVIEW 2.02 UG2 SOFTWARE. |
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