PMA P960040S406
- Device
- Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant, Pervica
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S406
- Product code
- LWS
- Decision date
- 2017-12-13
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for server and communicator software updates necessary for LATITUDE NXT Release 6.0.
Current openFDA PMA Record#
- Device
- Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant, Pervica
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S406
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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 6.0.