PMA P100023S033

Device
ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P100023
Supplement
S033
Product code
NIQ
Decision date
2012-08-20
Generic name
Coronary drug-eluting stent
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record

Device
ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P100023
Supplement
S033
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2012-08-20
Decision code
APPR
Date received
2012-01-11
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

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