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PMA P150012S105

Device
ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D
Applicant
Boston Scientific
PMA number
P150012
Supplement
S105
Product code
LWP
Decision date
2020-12-11
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
Move the Incoming Quality Assurance Acceptance Activity for testing levels of elements in Lithium Hydroxide from an external laboratory to the material supplier.

Current openFDA PMA Record#

Device
ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D
Applicant
Boston Scientific
PMA number
P150012
Supplement
S105
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2020-12-11
Decision code
OK30
Date received
2020-12-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Move the Incoming Quality Assurance Acceptance Activity for testing levels of elements in Lithium Hydroxide from an external laboratory to the material supplier.