PMA P060008S071

Device
Taxus Liberte Paclitaxel-eluting Coronary Stent Sy
Applicant
Boston Scientific Corp.
PMA number
P060008
Supplement
S071
Decision date
2011-06-30

Current openFDA PMA Record

Device
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS
Applicant
Boston Scientific Corp
PMA number
P060008
Supplement
S071
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2011-06-30
Decision code
OK30
Date received
2011-06-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IMPLEMENTATION OF THE USE OF A CLOSED-LOOP CONTROL (FEEDBACK), IN THE EXTRUSION OF THE TIE LAYER OF THE TRI-LAYER COMPONENT.

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