PMA P150012S044
- Device
- Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S044
- Product code
- LWP
- Decision date
- 2018-01-07
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for multiple software upgrades and updates for the Model 3300 Latitude Programming System.
Current openFDA PMA Record#
- Device
- Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S044
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2018-01-07
- Decision code
- APPR
- Date received
- 2017-10-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for multiple software upgrades and updates for the Model 3300 Latitude Programming System.