PMA P020009S124

Device
EXPRESS2 CORONARY STENT SYSTEM
Applicant
Boston Scientific Scimed, Inc.
PMA number
P020009
Supplement
S124
Product code
MAF
Decision date
2014-06-30
Generic name
STENT, CORONARY
Approval order statement
CHANGE TO THE STENT LASER CUTTING AND INSPECTION PROCESS.

Current openFDA PMA Record#

Device
EXPRESS2 CORONARY STENT SYSTEM
Applicant
Boston Scientific Scimed, Inc.
PMA number
P020009
Supplement
S124
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2014-06-30
Decision code
OK30
Date received
2014-06-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO THE STENT LASER CUTTING AND INSPECTION PROCESS.