PMA P010012S146
- Device
- CONTAK & RENEWAL FAMILIES OF CRT-DS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S146
- Product code
- LWP
- Decision date
- 2007-03-28
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR THE LATITUDE SYSTEM SOFTWARE, VERSION 2.1 (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE, VERSION 2.1.1 AND WEB APPLICATION SERVER (WAS) SOFTWARE, VERSION 2.1.1.
Current openFDA PMA Record#
- Device
- CONTAK & RENEWAL FAMILIES OF CRT-DS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S146
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2007-03-28
- Decision code
- APPR
- Date received
- 2007-01-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE LATITUDE SYSTEM SOFTWARE, VERSION 2.1 (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE, VERSION 2.1.1 AND WEB APPLICATION SERVER (WAS) SOFTWARE, VERSION 2.1.1.