VENTAK PRIZM DR/VR AICD
FDA premarket approval P960040/S012 · decided 2000-01-21
Approval details
- PMA number
- P960040
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK PRIZM DR/VR AICD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1999-08-23
- Decision date
- 2000-01-21
- Days to decision
- 151 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval is for modifications to VENTAK DR/VR AICD. The device, as modified, will be marketed under the tradename VENTAK PRIZM DR/VR AICD System, Models 1850, 1851, 1855 and 1856 with Model 2844 Software, Version 1.1 and the indications remains the same as in the original PMA.
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