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 | Pacemaker Devices - INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTONSCIENTIFIC 4100 HAMLINE AVENUE NORTH ST PAUL, MN 55112 |
PMA Number | P150012 |
Supplement Number | S088 |
Date Received | 01/03/2020 |
Decision Date | 04/01/2020 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for software changes included in LATITUDE NXT Patient Management System, Release 6.1.5 and associated changes in Server and Communicator software updates. |
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