PMA P100013S005

Device
EXOSEAL VASCULAR CLOSURE DEVICE
Applicant
Cordis US Corporation
PMA number
P100013
Supplement
S005
Product code
MGB
Decision date
2012-08-14
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
IMPLEMENTATION CHANGES TO THE POUCH SEALING PROCESS.

Current openFDA PMA Record#

Device
EXOSEAL VASCULAR CLOSURE DEVICE
Applicant
Cordis US Corporation
PMA number
P100013
Supplement
S005
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2012-08-14
Decision code
OK30
Date received
2012-07-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IMPLEMENTATION CHANGES TO THE POUCH SEALING PROCESS.