PMA P040016S120

Device
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM
Applicant
Boston Scientific Scimed, Inc.
PMA number
P040016
Supplement
S120
Product code
MAF
Decision date
2014-01-29
Generic name
STENT, CORONARY
Approval order statement
REMOVE THE METALS CONTENT LOAD TEST USED FOR THE MONITORING OF ELECTROPOLISHING SOLUTIONS.

Current openFDA PMA Record#

Device
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM
Applicant
Boston Scientific Scimed, Inc.
PMA number
P040016
Supplement
S120
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2014-01-29
Decision code
OK30
Date received
2013-12-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REMOVE THE METALS CONTENT LOAD TEST USED FOR THE MONITORING OF ELECTROPOLISHING SOLUTIONS.