ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI
FDA premarket approval P150012/S068 · decided 2019-05-23
Approval details
- PMA number
- P150012
- Supplement
- S068
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-12-18
- Decision date
- 2019-05-23
- Days to decision
- 156 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for modifying the Accolade family including pacemakers and CRT-P devices.
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