PMA P120016S023

Device
VASCADE 6/7f VCS & VASCADE 5F VCS
Applicant
Cardiva Medical, Inc.
PMA number
P120016
Supplement
S023
Product code
MGB
Decision date
2017-04-11
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Addition of an alternate, in-house supplier for the pad-printed Distal Outer Sleeve.

Current openFDA PMA Record#

Device
VASCADE 6/7f VCS & VASCADE 5F VCS
Applicant
Cardiva Medical, Inc.
PMA number
P120016
Supplement
S023
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2017-04-11
Decision code
OK30
Date received
2017-03-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an alternate, in-house supplier for the pad-printed Distal Outer Sleeve.