PMA P010012S465
- Device
- Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S465
- Product code
- NIK
- Decision date
- 2017-12-13
- 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 server and communicator software updates necessary for LATITUDE NXT Release 6.
Current openFDA PMA Record#
- Device
- Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S465
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-12-13
- Decision code
- APPR
- Date received
- 2017-09-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for server and communicator software updates necessary for LATITUDE NXT Release 6.