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 | INVIVE,INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-P) |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | GUIDANT CORP. 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P030005 |
Supplement Number | S099 |
Date Received | 05/22/2013 |
Decision Date | 07/25/2013 |
Product Codes |
NKE OSR |
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 MODEL 2869 ZOOMVIEW PROGRAMMER SOFTWARE APPLICATION V1.09 AND INGENIO FIRMWARE VERSION D_V1.02 WITH PATCH V1.01 FOR THE DEVICES. |
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