PMA P110035S005

Device
VASCULAR SELF-EXPANDING STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P110035
Supplement
S005
Product code
NIO
Decision date
2012-12-11
Classification
Stent, Iliac
Generic name
STENT, ILIAC
Approval order statement
USE OF AN ELECTRONIC RECORDS SYSTEM.

Current openFDA PMA Record#

Device
VASCULAR SELF-EXPANDING STENT SYSTEM
Applicant
Boston Scientific Corp
PMA number
P110035
Supplement
S005
Product code
NIO
Generic name
STENT, ILIAC
Decision date
2012-12-11
Decision code
OK30
Date received
2012-11-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
USE OF AN ELECTRONIC RECORDS SYSTEM.