- Device
- ImageReady MR Conditional Pacing System and INGEVITY Pace/Sense Lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S096
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-08-26
- Decision code
- APPR
- Date received
- 2020-07-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for labeling updates for the ImageReady MR Conditional Pacing System and INGEVITY Pace/Sense Lead based on the SAMURAI and INGEVITY clinical studies.