VENTAK PRIZM 2DR/VR AICD SYSTEMS & MODEL 2844, VERSION 3.1 SOFTWARE
FDA premarket approval P960040/S015 · decided 2000-08-04
Approval details
- PMA number
- P960040
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK PRIZM 2DR/VR AICD SYSTEMS & MODEL 2844, VERSION 3.1 SOFTWARE
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2000-06-08
- Decision date
- 2000-08-04
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE PULSE GENERATOR MODELS 1860 AND 1861, PULSE GENERATOR SOFTWARE VERSION 1.3, AND PROGRAM/RECORDER/MONITOR SOFTWARE MODEL 2844, VERSION 3.1.
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