PMA P100023S076

Device
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp.
PMA number
P100023
Supplement
S076
Product code
NIQ 
Decision date
2014-08-28
Generic name
Coronary Drug-eluting Stent
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record

Device
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P100023
Supplement
S076
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2014-08-28
Decision code
APPR
Date received
2013-08-05
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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