Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, Accolade MRI
FDA premarket approval P150012/S052 · decided 2018-03-26
Approval details
- PMA number
- P150012
- Supplement
- S052
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, Accolade MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-01-18
- Decision date
- 2018-03-26
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a Software Maintenance Release (SMR) for the Model 3922 Pacing System Analyzer (PSA) Software Application that functions within Model 3300 LATITUDE Programming System (LPS).
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