PMA P010012S492
- Device
- COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM and VIGILIANT (CRT-D Resynchroni
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S492
- Product code
- NIK
- Decision date
- 2019-02-22
- 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 changes to the Server and Communicator software updates necessary for LATITUDE NXT Release.
Current openFDA PMA Record#
- Device
- COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM and VIGILIANT (CRT-D Resynchroni
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S492
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2019-02-22
- Decision code
- APPR
- Date received
- 2018-12-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the Server and Communicator software updates necessary for LATITUDE NXT Release.