PMA P100013S007

Device
EXCOSEAL VASCULAR CLOSURE DEVICE
Applicant
Cordis US Corporation
PMA number
P100013
Supplement
S007
Product code
MGB
Decision date
2012-12-13
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
ALTERNATE STERILIZATION MINIMUM DOSE.

Current openFDA PMA Record#

Device
EXCOSEAL VASCULAR CLOSURE DEVICE
Applicant
Cordis US Corporation
PMA number
P100013
Supplement
S007
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2012-12-13
Decision code
OK30
Date received
2012-11-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE STERILIZATION MINIMUM DOSE.