PMA P050007S026

Device
STARCLOSE SE VASCULAR CLOSURE SYSTEM
Applicant
Abbott Vascular Devices
PMA number
P050007
Supplement
S026
Product code
MGB
Decision date
2010-06-03
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
INCREASE IN ADHESIVE DISPENSING TIME.

Current openFDA PMA Record#

Device
STARCLOSE SE VASCULAR CLOSURE SYSTEM
Applicant
Abbott Vascular Devices
PMA number
P050007
Supplement
S026
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2010-06-03
Decision code
OK30
Date received
2010-05-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
INCREASE IN ADHESIVE DISPENSING TIME.