PMA P100023S063

Device
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp.
PMA number
P100023
Supplement
S063
Product code
NIQ 
Decision date
2012-12-11
Generic name
Coronary Drug-eluting Stent
Approval order statement
REMOVAL OF TWO IN-PROCESS INSPECTIONS.

Current openFDA PMA Record

Device
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P100023
Supplement
S063
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2012-12-11
Decision code
OK30
Date received
2012-11-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REMOVAL OF TWO IN-PROCESS INSPECTIONS.

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