PMA P910077S023
- Device
- VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S023
- Product code
- LWS
- Decision date
- 1998-07-31
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for an update to the Model 2881 Software Application to inlcude the DELTA/VISTA pacemakers series, resulting in Version 1.3 of the Model 2881 Software Application.
Current openFDA PMA Record#
- Device
- VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S023
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1998-07-31
- Decision code
- APPR
- Date received
- 1998-06-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an update to the Model 2881 Software Application to inlcude the DELTA/VISTA pacemakers series, resulting in Version 1.3 of the Model 2881 Software Application.