PMA P100023S120

Device
ION PACLITAXEL ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P100023
Supplement
S120
Product code
NIQ
Decision date
2015-07-01
Generic name
Coronary drug-eluting stent
Approval order statement
SOFTWARE AND HARDWARE UPDATED TO AN EXISTING MANUAL POLISHING LINE.

Current openFDA PMA Record

Device
ION PACLITAXEL ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P100023
Supplement
S120
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2015-07-01
Decision code
OK30
Date received
2015-06-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
SOFTWARE AND HARDWARE UPDATED TO AN EXISTING MANUAL POLISHING LINE.

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