PMA P150012S060
- Device
- INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers, INGEVITY MRI Lead, Slit Sutu
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S060
- Product code
- LWP
- Decision date
- 2018-07-27
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for firmware modifications for the Ingenio and Accolade families of pacemaker and cardiac resynchronization therapy-pacemaker pulse generators and the associated Programmer Software Applications to support the addition of features including Signal Artifact Monitor, Automatic Lead Recognition, MRI Protection Mode, and RightRate pacing. The device, as modified, will be marketed under the trade names listed for pacemakers and CRT P devices.. Adaptive rate pacing is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with increases in minute ventilation and/or physical activity.
Current openFDA PMA Record#
- Device
- INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers, INGEVITY MRI Lead, Slit Sutu
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S060
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2018-07-27
- Decision code
- APPR
- Date received
- 2018-04-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for firmware modifications for the Ingenio and Accolade families of pacemaker and cardiac resynchronization therapy-pacemaker pulse generators and the associated Programmer Software Applications to support the addition of features including Signal Artifact Monitor, Automatic Lead Recognition, MRI Protection Mode, and RightRate pacing. The device, as modified, will be marketed under the trade names listed for pacemakers and CRT P devices.. Adaptive rate pacing is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with increases in minute ventilation and/or physical activity.