PMA P100023S074

Device
ION (TAXUS ELEMENT CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P100023
Supplement
S074
Product code
NIQ
Decision date
2013-07-09
Generic name
Coronary drug-eluting stent
Approval order statement
CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.

Current openFDA PMA Record

Device
ION (TAXUS ELEMENT CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P100023
Supplement
S074
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2013-07-09
Decision code
OK30
Date received
2013-06-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.

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