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 | VENTAK PRIZM AICD, VENTAK PRIZM HE AICE, VENTAK PRIZM 2 AICD AND VITALITY DS/EL AICD SYSTEMS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S041 |
Date Received | 01/16/2004 |
Decision Date | 03/09/2004 |
Product Codes |
KRG 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 FIRMWARE MODIFICATIONS OF THE FOLLOWING AICD SYSTEMS: VENTAK PRIZM AICD SYSTEM (MODELS 1850, 1851, 1855, 1856) FIRMWARE VERSION 1.2 PATCH H, VENTAK PRIZM HE AICD SYSTEM (MODELS 1852, 1853, 1857, 1858) FIRMWARE VERSION 1.2 PATCH H, VENTAK PRIZM 2 AICD SYSTEM (MODELS 1860, 1861) FIRMWARE VERSION 1.4 PATCH C, VITALITY DS/EL AICD SYSTEM (MODELS T125, T127, T135) FIRMWARE VERSION 1.0 PATCH B, CONTAK CD 2 (MODELS H115, H119) FIRMWARE VERSION 1.2 PATCH H, AND THE APPLICATION SOFTWARE MODEL 2844 VERSION 3.7. |
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