PMA P100023S069

Device
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P100023
Supplement
S069
Product code
NIQ
Decision date
2013-05-15
Generic name
Coronary drug-eluting stent
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT BALLYBRIT BUSINESS PARK, IN GALWAY, IRELAND.

Current openFDA PMA Record

Device
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P100023
Supplement
S069
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2013-05-15
Decision code
APPR
Date received
2013-02-01
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 BALLYBRIT BUSINESS PARK, IN GALWAY, IRELAND.

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