INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers, INGEVITY MRI Lead, Slit Sutu
FDA premarket approval P150012/S060 · decided 2018-07-27
Approval details
- PMA number
- P150012
- Supplement
- S060
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers, INGEVITY MRI Lead, Slit Sutu
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-04-30
- Decision date
- 2018-07-27
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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 e
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