Pacemaker Devices: INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI
FDA premarket approval P150012/S081 · decided 2019-10-18
Approval details
- PMA number
- P150012
- Supplement
- S081
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Pacemaker Devices: INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2019-07-22
- Decision date
- 2019-10-18
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for modifying the Model 3300 LATITUDE Programming System software components to update the Brady device application code base, add support for 4G cellular communications, and add an integrated Heart Connect application.
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