PMA P840068S019
- Device
- VISTA DDD MODEL 942 & 944 AND SOFTWARE MODULE MODEL 2052
- Applicant
- Boston Scientific
- PMA number
- P840068
- Supplement
- S019
- Product code
- LWP
- Decision date
- 1996-06-19
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR TWO NEW MODELS OF VISTA DDD PULSE GENERATORS AND A SOFTWARE MODULE. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME VISTA DDD MODEL 942, VISTA DDD MODEL 944 AND SOFTWARE MODULE MODEL 2052 WITH THE COMMERCIALLY AVAILABLE HANDHELD PROGRAMMER MODEL 2035
Current openFDA PMA Record#
- Device
- VISTA DDD MODEL 942 & 944 AND SOFTWARE MODULE MODEL 2052
- Applicant
- Boston Scientific
- PMA number
- P840068
- Supplement
- S019
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1996-06-19
- Decision code
- APPR
- Date received
- 1992-05-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR TWO NEW MODELS OF VISTA DDD PULSE GENERATORS AND A SOFTWARE MODULE. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME VISTA DDD MODEL 942, VISTA DDD MODEL 944 AND SOFTWARE MODULE MODEL 2052 WITH THE COMMERCIALLY AVAILABLE HANDHELD PROGRAMMER MODEL 2035