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PMA P170008S011

Device
EluNIR™ Ridaforolimus Eluting Coronary Stent System
Applicant
Medinol, Ltd.
PMA number
P170008
Supplement
S011
Product code
NIQ
Decision date
2019-02-13
Classification
Coronary Drug-eluting Stent
Generic name
Coronary drug-eluting stent
Approval order statement
Approval for introduction of a new analytical test method for determination of the concentration of the polymers in the drug solution, and removal of certain tests for the polymer stock solutions and the drug solution.

Current openFDA PMA Record#

Device
EluNIR™ Ridaforolimus Eluting Coronary Stent System
Applicant
Medinol, Ltd.
PMA number
P170008
Supplement
S011
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2019-02-13
Decision code
APPR
Date received
2018-10-31
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for introduction of a new analytical test method for determination of the concentration of the polymers in the drug solution, and removal of certain tests for the polymer stock solutions and the drug solution.