FDA.reportPublic FDA data

PMA P150012S089

Device
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,
Applicant
Boston Scientific
PMA number
P150012
Supplement
S089
Product code
LWP
Decision date
2020-01-28
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order 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.

Current openFDA PMA Record#

Device
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,
Applicant
Boston Scientific
PMA number
P150012
Supplement
S089
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2020-01-28
Decision code
OK30
Date received
2020-01-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.