VENTAK VITALITY AVT AICD SYSTEM (MODEL A135)
FDA premarket approval P960040/S042 · decided 2004-03-19
Approval details
- PMA number
- P960040
- Supplement
- S042
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VENTAK VITALITY AVT AICD SYSTEM (MODEL A135)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2004-01-21
- Decision date
- 2004-03-19
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE SYSTEM GUIDE LABELING REINSERT (CHANGE TACHY MODE WITH MAGNET FEATURE).
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