PMA P100023S038

Device
ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P100023
Supplement
S038
Product code
NIQ
Decision date
2012-08-16
Generic name
Coronary drug-eluting stent
Approval order statement
APPROVAL FOR HARDWARE AND SOFTWARE CHANGES TO THE CATHETER PORT MANUFACTURING PROCESS.

Current openFDA PMA Record

Device
ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P100023
Supplement
S038
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2012-08-16
Decision code
APPR
Date received
2012-03-20
Supplement type
135 Review Track For 30-Day Notice
Approval order statement
APPROVAL FOR HARDWARE AND SOFTWARE CHANGES TO THE CATHETER PORT MANUFACTURING PROCESS.

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