PMA P100023S094

Device
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp.
PMA number
P100023
Supplement
S094
Product code
NIQ 
Decision date
2014-05-01
Generic name
Coronary Drug-eluting Stent
Approval order statement
CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.

Current openFDA PMA Record

Device
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P100023
Supplement
S094
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2014-05-01
Decision code
OK30
Date received
2014-03-31
Supplement type
30-Day Notice
Approval order statement
CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.

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