PMA P060008S019

Device
TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P060008
Supplement
S019
Product code
NIQ
Decision date
2009-09-30
Generic name
Coronary drug-eluting stent
Approval order statement
ELIMINATION OF AN IN-PROCESS CLEANING OF COMPONENTS FOR THE DEVICE.

Current openFDA PMA Record

Device
TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P060008
Supplement
S019
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2009-09-30
Decision code
OK30
Date received
2009-08-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ELIMINATION OF AN IN-PROCESS CLEANING OF COMPONENTS FOR THE DEVICE.

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