PMA P150012S043
- Device
- IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S043
- Product code
- LWP
- Decision date
- 2017-12-13
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for server and communicator software updates necessary for LATITUDE NXT Release 6.0.
Current openFDA PMA Record#
- Device
- IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S043
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (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.