ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI
FDA premarket approval P150012/S062 · decided 2018-07-17
Approval details
- PMA number
- P150012
- Supplement
- S062
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-05-04
- Decision date
- 2018-07-17
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for an inner tray redesign for the packaging used for the standard life (SL) Accolade pacemakers..
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