PMA P010012S207
- Device
- COGNIS CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S207
- Product code
- LWP
- Decision date
- 2009-05-26
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR THE PROGRAMMER SW MODEL 2868 V1.05 FOR THE TELIGEN AND COGNIS FAMILIES OF DEVICES.
Current openFDA PMA Record#
- Device
- COGNIS CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S207
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2009-05-26
- Decision code
- APPR
- Date received
- 2009-04-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE PROGRAMMER SW MODEL 2868 V1.05 FOR THE TELIGEN AND COGNIS FAMILIES OF DEVICES.