PMA P010012S084
- Device
- CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S084
- Product code
- LWP
- Decision date
- 2005-12-20
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR THE HEART FAILURE PARTNER MODEL 2936 MAINTENANCE RELEASE SOFTWARE (SW) VERSION 1.5.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S084
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2005-12-20
- Decision code
- APPR
- Date received
- 2005-12-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE HEART FAILURE PARTNER MODEL 2936 MAINTENANCE RELEASE SOFTWARE (SW) VERSION 1.5.