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 | VALITUDE™, VALITUDE™ X4, VISIONIST™, VISIONIST™ X4 |
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 | S220 |
Date Received | 08/25/2022 |
Decision Date | 11/08/2022 |
Product Code |
NKE |
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 a software maintenance release to update the Model 3869 Brady programmer software application and Accolade pulse generator firmware. |
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