PMA P150012S083
- Device
- Ingevity + Lead - Active Fixation
- Applicant
- Boston Scientific
- Product code
- LWP
- Decision date
- 2019-12-16
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval to add the INGEVITY+ (plus) leads to the INGEVITY MRI lead family.
Current openFDA PMA Record#
- Device
- Ingevity + Lead - Active Fixation
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S083
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2019-12-16
- Decision code
- APPR
- Date received
- 2019-09-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to add the INGEVITY+ (plus) leads to the INGEVITY MRI lead family.