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PMA P150012S102

Device
PG ACCOLADE MRI DR, PG ACCOLADE MRI SR, PG ESSENTIO MRI DR, PG ESSENTIO MRI SR, PG PROPONENT MRI DR, and PG PROPONENT M
Applicant
Boston Scientific
PMA number
P150012
Supplement
S102
Product code
LWP
Decision date
2020-10-22
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
Change the inspection criteria, cycle duration, brush life, and gowning requirements for the automated de-burring process of pulse generator case halves.

Current openFDA PMA Record#

Device
PG ACCOLADE MRI DR, PG ACCOLADE MRI SR, PG ESSENTIO MRI DR, PG ESSENTIO MRI SR, PG PROPONENT MRI DR, and PG PROPONENT M
Applicant
Boston Scientific
PMA number
P150012
Supplement
S102
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2020-10-22
Decision code
OK30
Date received
2020-10-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change the inspection criteria, cycle duration, brush life, and gowning requirements for the automated de-burring process of pulse generator case halves.