PMA P100023S042

Device
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P100023
Supplement
S042
Product code
NIQ
Decision date
2012-05-23
Generic name
Coronary drug-eluting stent
Approval order statement
UPGRADES TO STERILIZATION EQUIPMENT.

Current openFDA PMA Record

Device
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P100023
Supplement
S042
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2012-05-23
Decision code
OK30
Date received
2012-04-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
UPGRADES TO STERILIZATION EQUIPMENT.

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