PMA P150012S067
- Device
- INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI (Pacemaker Devices)
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S067
- Product code
- LWP
- Decision date
- 2019-02-22
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for changes to the Server and Communicator software updates necessary for LATITUDE NXT Release.
Current openFDA PMA Record#
- Device
- INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI (Pacemaker Devices)
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S067
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (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.