PMA P120016S015

Device
VASCADE VASCULAR CLOSURE SYSTEM (VCS)
Applicant
Cardiva Medical, Inc.
PMA number
P120016
Supplement
S015
Product code
MGB
Decision date
2015-07-08
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
APPROVAL FOR A CHANGE IN THE DEPLOYMENT FORCE PERFORMANCE SPECIFICATION FOR THE VASCADE 5F AND 6/7F DEVICE.

Current openFDA PMA Record#

Device
VASCADE VASCULAR CLOSURE SYSTEM (VCS)
Applicant
Cardiva Medical, Inc.
PMA number
P120016
Supplement
S015
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2015-07-08
Decision code
APPR
Date received
2015-05-18
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A CHANGE IN THE DEPLOYMENT FORCE PERFORMANCE SPECIFICATION FOR THE VASCADE 5F AND 6/7F DEVICE.