PMA P910077S168
- Device
- LATITUDE NXT Patient Management System, LATITUDE Wave Communicator, LATITUDE Consult Communicator and LATITUDE NXT Syste
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S168
- Product code
- LWS
- Decision date
- 2019-02-22
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for changes to the Server and Communicator software updates necessary for LATITUDE NXT Release 6.1.
Current openFDA PMA Record#
- Device
- LATITUDE NXT Patient Management System, LATITUDE Wave Communicator, LATITUDE Consult Communicator and LATITUDE NXT Syste
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S168
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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 6.1.