Essentio, Proponent, and Accolade MRI Pacemakers
FDA premarket approval P150012/S080 · decided 2019-09-18
Approval details
- PMA number
- P150012
- Supplement
- S080
- 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
- 2019-06-20
- Decision date
- 2019-09-18
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for hardware modifications to the IS-1 lead bore cavity and spring coil in the IS-1 pulse generator (PG) header for all pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) within the Accolade family and a subset of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D) within the NG3 and NG4 families.
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