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PMA P800036S041

Device
INFUSAID Implantable Infusion Pump and Accessories
Applicant
Intera Oncology
PMA number
P800036
Supplement
S041
Product code
LKK
Decision date
2020-02-07
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Approval for a manufacturing site located at Intera Oncology, Inc., 65 William Street, Suite 200, Wellesley, Massachusetts, to conduct quality system activities.

Current openFDA PMA Record#

Device
INFUSAID Implantable Infusion Pump and Accessories
Applicant
Intera Oncology
PMA number
P800036
Supplement
S041
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2020-02-07
Decision code
APPR
Date received
2020-01-09
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Intera Oncology, Inc., 65 William Street, Suite 200, Wellesley, Massachusetts, to conduct quality system activities.