PG ESSENTION MRI SR/DR SL, PG ESSENTIO DR EL, PG ESSENTIO MRI DR EL, PG PROPONENT MRI SR/DR/ SL, PG PROPONENT MRI DR EL,
FDA premarket approval P150012/S089 · decided 2020-01-28
Approval details
- PMA number
- P150012
- Supplement
- S089
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PG ESSENTION MRI SR/DR SL, PG ESSENTIO DR EL, PG ESSENTIO MRI DR EL, PG PROPONENT MRI SR/DR/ SL, PG PROPONENT MRI DR EL,
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2020-01-27
- Decision date
- 2020-01-28
- Days to decision
- 1 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Reduce the burn-in process temperature setting used during manufacturing of the Integrated Circuit modules of the NG3/NG4 and Accolade Pulse Generator product families.
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