PMA P050007S014

Device
VASCULAR CLOSURE SYSTEMS
Applicant
Abbott Vascular Devices
PMA number
P050007
Supplement
S014
Product code
MGB
Decision date
2009-07-09
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO FOR ETHYLENE OXIDE STERILIZATION.

Current openFDA PMA Record#

Device
VASCULAR CLOSURE SYSTEMS
Applicant
Abbott Vascular Devices
PMA number
P050007
Supplement
S014
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2009-07-09
Decision code
APPR
Date received
2009-05-28
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO FOR ETHYLENE OXIDE STERILIZATION.