PMA P060008S039

Device
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P060008
Supplement
S039
Product code
NIQ
Decision date
2010-02-03
Generic name
Coronary drug-eluting stent
Approval order statement
REMOVAL OF AN IN-PROCESS INSPECTION WHICH IS PERFORMED ON THE INNER DIAMETER (ID) OF THE STENT COMPONENT.

Current openFDA PMA Record

Device
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P060008
Supplement
S039
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2010-02-03
Decision code
OK30
Date received
2010-01-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REMOVAL OF AN IN-PROCESS INSPECTION WHICH IS PERFORMED ON THE INNER DIAMETER (ID) OF THE STENT COMPONENT.

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