PMA P840068S040
- Device
- DELTA/VISTA
- Applicant
- Boston Scientific
- PMA number
- P840068
- Supplement
- S040
- Product code
- LWP
- Decision date
- 2000-12-13
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR THE VENTAK(R) AV DDD/ AV II DDD MODEL 2833 VERSION 4.0 SOFTWARE, THE VENTAK(R) VR MODEL 2841 VERSION 4.0 SOFTWARE AND THE DELTA(R)/ VISTA MODEL 2881 VERSION 2.0 SOFTWARE.
Current openFDA PMA Record#
- Device
- DELTA/VISTA
- Applicant
- Boston Scientific
- PMA number
- P840068
- Supplement
- S040
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2000-12-13
- Decision code
- APPR
- Date received
- 2000-07-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE VENTAK(R) AV DDD/ AV II DDD MODEL 2833 VERSION 4.0 SOFTWARE, THE VENTAK(R) VR MODEL 2841 VERSION 4.0 SOFTWARE AND THE DELTA(R)/ VISTA MODEL 2881 VERSION 2.0 SOFTWARE.