VENTAK PRIZM AVT
FDA premarket approval P960040/S033 · decided 2003-06-25
Approval details
- PMA number
- P960040
- Supplement
- S033
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK PRIZM AVT
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2003-05-22
- Decision date
- 2003-06-25
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE VENTAK PRIZM AVT AICD, MODEL 2849, PROGRAMMER SOFTWARE VERSION 2.5.
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