VENTAK PRIZM AICD, VENTAK PRIZM HE AICE, VENTAK PRIZM 2 AICD AND VITALITY DS/EL AICD SYSTEMS
FDA premarket approval P960040/S041 · decided 2004-03-09
Approval details
- PMA number
- P960040
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 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
- Date received
- 2004-01-16
- Decision date
- 2004-03-09
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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 M
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