PMA P940019S026

Device
WALLSTENT (IIIAC) ENDOPROSTHESIS
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S026
Product code
MAF
Decision date
2011-08-04
Classification
Stent, Coronary
Generic name
STENT, CORONARY
Approval order statement
ALTERNATE VENDOR FOR THE DISTAL TIP COMPONENT OF THE DELIVERY SYSTEM FOR THE DEVICES.

Current openFDA PMA Record#

Device
WALLSTENT (IIIAC) ENDOPROSTHESIS
Applicant
Boston Scientific Scimed, Inc.
PMA number
P940019
Supplement
S026
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2011-08-04
Decision code
OK30
Date received
2011-07-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE VENDOR FOR THE DISTAL TIP COMPONENT OF THE DELIVERY SYSTEM FOR THE DEVICES.