PMA P910077S076
- Device
- VENTAK MINI AICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S076
- Product code
- LWS
- Decision date
- 2007-12-20
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL TO UPDATE THE SYSTEM SOFTWARE MODEL 2909 FROM V4.4 TO V6.0 FOR THE RUN TIME ENVIRONMENT OF THE MODEL 3120 PRM.
Current openFDA PMA Record#
- Device
- VENTAK MINI AICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S076
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2007-12-20
- Decision code
- APPR
- Date received
- 2007-08-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO UPDATE THE SYSTEM SOFTWARE MODEL 2909 FROM V4.4 TO V6.0 FOR THE RUN TIME ENVIRONMENT OF THE MODEL 3120 PRM.