PMA P010012S355
- Device
- COGNIS, PROGENY CRT-D AND NG CRT-D MODELS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S355
- Product code
- NIK
- Decision date
- 2014-07-16
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- APPROVAL FOR MODEL 2868 APPLICATION SOFTWARE VERSION 3.04 AND FIRMWARE VERSION A_V1.04 WITH PATCH V4.01 AND FIRMWARE VERSION B_V1.02 WITH PATCH V3.01 FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- COGNIS, PROGENY CRT-D AND NG CRT-D MODELS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S355
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2014-07-16
- Decision code
- APPR
- Date received
- 2014-05-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODEL 2868 APPLICATION SOFTWARE VERSION 3.04 AND FIRMWARE VERSION A_V1.04 WITH PATCH V4.01 AND FIRMWARE VERSION B_V1.02 WITH PATCH V3.01 FOR THE DEVICES.