Essentio, Proponent and Accolade MRI Pacemakers
FDA premarket approval P150012/S013 · decided 2016-10-04
Approval details
- PMA number
- P150012
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Essentio, Proponent and Accolade MRI Pacemakers
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-07-29
- Decision date
- 2016-10-04
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for an alternate capacitor in the medical implant communication service module component.
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