VENTAK AV III DR PULSE GENERATOR AND VENTAK AV DR SOFTWARE APPLICATION
FDA premarket approval P960040/S006 · decided 1998-08-31
Approval details
- PMA number
- P960040
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK AV III DR PULSE GENERATOR AND VENTAK AV DR SOFTWARE APPLICATION
- Applicant
- Boston Scientific
- Date received
- 1998-04-22
- Decision date
- 1998-08-31
- Days to decision
- 131 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the VENTAK(R) AV III DR AICD(TM) System with Model 2843 Software, Version 2.6, the use of Version 2.6 with the VENTAK(R) AV II DR System and modifications to the Physician's Manual and the DR System and modifications tot he Physicians's Manual and the Patient's Manual.
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