- Device
- INGEVITY™ MRI Leads, Slit Suture Sleeve Accessory for INGEVITY Leads (Pacing Leads and Accessories)
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S032
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2017-09-20
- Decision code
- APPR
- Date received
- 2017-05-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to label a subset of the market released devices as ImageReady MR Conditional Defibrillation System.